Sökresultat för "EU Regulatory Compliance"

Quality Engineer to our client Are you an experienced quality engineer with a solid understanding of EU regulatory compliance and product certifications? We are now looking for a Quality Engineer for a consultancy assignment with an established international company with a strong digital presence and operations across multiple European markets. If you enjoy combining technical product knowledge with compliance work and supplier contact – this could be the assignment for you. About the assignment Our client is an international company with a strong market position, a broad product portfolio and operations in multiple countries. You will be responsible for quality assurance and product compliance for hard goods within a specific product category, with a focus on certifications and EU regulatory adherence. You will report to the QA & Compliance Manager and work closely with commercial teams, suppliers, logistics and internal stakeholders. Responsibilities Product compliance & certification Manage the certification process including validation of test reports and creation of Declaration of Conformity (DoC). Maintain documentation related to product compliance and EU regulations such as CE and EUDR. Quality assurance Identify root causes of quality issues, customer complaints and product-related claims. Manage product inspections and release goods for shipment. Ensure correct product labelling and creation of manuals and instructions. Product development & supplier contact Collaborate with commercial teams on new product developments through risk assessments, sample reviews and technical specification creation. Act as the main contact to suppliers regarding quality and compliance matters. Guidelines & internal support Maintain and update quality guidelines such as the Quality Manual when laws, standards or internal procedures change. Support internal teams with in-depth product knowledge on relevant standards, certifications and applicable processes. We are looking for someone who Is structured, analytical and detail-oriented with high professional integrity in supplier relations. You are self-organised, flexible and comfortable in an environment where processes and ways of working are continuously evolving. You have strong collaboration skills and are used to working cross-functionally with multiple internal and external stakeholders. Requirements & qualifications Degree in a relevant technical field such as Engineering, Product Development, Quality Management or Product Compliance – or equivalent experience Minimum 4–5 years of relevant experience within quality assurance, product compliance, certification or supplier quality management Experience with EU product compliance and applicable standards such as GPSR, REACH, RoHS, RED, Battery Regulation, WEEE, EUDR and PPWR Good knowledge of Microsoft Office (Excel, Word, PowerPoint) Strong problem-solving and analytical skills Strong cross-functional collaboration skills Meriting experience Experience from consumer products such as hard goods, electronics, PPE or other regulated product categories Experience with technical documentation, risk assessments and supplier quality processes Experience with Adobe Illustrator, Photoshop/InDesign or CAD software Location & scope Stockholm - 100% Application To apply for assignments via Jappa, you need to create a consultant profile on our platform and submit your application. By doing so, your profile will also become visible to other clients looking for commercial and specialist consultants for future assignments. Spend 10–15 minutes creating your profile today to be considered for exciting opportunities. We have replaced traditional recruitment with a smart marketplace, industry expertise, quality-assured processes and AI. The result is clearer matches, faster responses and happier consultants and clients alike. With Jappa, finding the right assignment is simple. We give you access to a wide range of opportunities within e-commerce and tech – from shorter freelance assignments to longer engagements and permanent roles. Jappa is a talent-as-a-service solution where you, as a consultant, are at the centre. We always strive to match you with assignments where you can truly make a difference and grow.

Are you a confident expert in regulatory compliance with a strong customer focus and a passion for sharing knowledge? In this role, you’ll act as a trusted advisor to our customers, guiding them through regulatory requirements for market access — particularly across Europe. You’ll lead compliance projects, deliver expert training, and help shape and grow our Regulatory Compliance Project Management service. Key Responsibilities: · Help define and continuously develop and evolve our advisory service “Regulatory Compliance Project Management” · Advise customers on CE marking, UKCA, and EU regulatory requirements · Perform strategic compliance project management projects · Deliver training sessions and courses online and in-person · Support the sales team by identifying opportunities and contributing to business growth · Collaborate with colleagues and customers across international markets · Take ownership of your professional development while actively contributing to the growth and advancement of your area of responsibility Your background should involve: · Post-secondary degree or diploma in a relevant field or equivalent work experience · Excellent knowledge and experience of work with regulatory requirements, testing and certification of electrical products for market access · Strong knowledge within LVD, EMC, RED and MD · Strong knowledge of the CE marking process, in both theory and practice · Excellent communication skills, in both Swedish and English Ability to teach within the area of regulatory requirements for electrical products You combine strong technical expertise with a consultative, customer-focused approach. You thrive in a fast-paced, evolving environment and are able to adapt to changing priorities. You are both detail-oriented and strategic in your thinking, enabling you to see the bigger picture while maintaining high accuracy. You build strong relationships and inspire trust among colleagues and customers alike. You take ownership of your work and are driven to deliver results. Intertek offers: Meaningful work that contributes to product safety and reliability Opportunities for professional development and long-term career growth A collaborative and supportive work environment Exposure to a wide range of products, technologies, and industries The chance to work within a truly global organization Intertek is a leading Total Quality Assurance provider to industries worldwide. With a 125-year legacy of excellence, our global network delivers innovative and bespoke Assurance, Testing, Inspection, and Certification solutions for our customers' operations and supply chains. Our extensive global network of accredited laboratories and world-class experts are dedicated to addressing quality, safety, and sustainability across a vast spectrum of industries, including Medical, Lighting, Renewable Energy, HVACR, Appliances & Electronics, Connected World (IoT), and many more. Global manufacturers trust Intertek for faster, simpler, and more cost-efficient services that clear a path for their product's success. Join us and be a part of a team that continually exceeds client expectations and sets the standard for quality and accuracy.

ABOUT US Legora is redefining how legal work gets done. Not built for lawyers, built with them. We work alongside the world’s best legal teams, who expect excellence, precision, and speed, and we hold ourselves to the same bar. Our AI-native workspace lets legal professionals move faster, think more clearly, and operate with sharper precision. By analysing thousands of documents in minutes and powering end-to-end workflows, we cut through complexity, teams can focus on what matters: judgment, strategy, and outcomes. 1,000+ customers across 50+ countries trust us, including Cleary Gottlieb, Goodwin, Linklaters, White & Case, Dentons, and Barclays. We’ve scaled to $100M+ in ARR, with teams across Europe, North America and APAC, and continue to expand through acquisitions including Qura, Walter AI and Graceview. We partner with world-class performers: including Aaron Judge and the New York Yankees, Ludvig Åberg (and his caddie), and campaigns featuring Jude Law. Joining Legora means three things. * We lean in: ownership over titles, outcomes over intentions. * We fight for excellence: high standards, direct, ego-free feedback. * We grow together: as a team and with our customers. Mission before ego. Everyone contributes. No one coasts. If you’re driven by impact, pace, and raising the bar. This is the place. The role As Regulatory & Compliance Counsel at Legora, you will be central to our legal technology innovation, ensuring regulatory compliance, managing legal risks, and supporting business operations across all teams. As part of the legal team, you will provide compliance guidance to commercial and product teams on matters ranging from data privacy to AI governance. This is a high-trust, high-responsibility role with clear business impact, requiring you to operate with autonomy, sound judgment, and precise execution. You will serve as a strategic partner to product development, InfoSec, and commercial teams, leveraging your legal expertise to identify solutions and drive innovation in our mission to transform legal work globally. What you will be doing: * Provide compliance oversight and guidance to senior stakeholders across operational, commercial and product teams on regulatory matters, risk assessment, and compliance frameworks for new services, processes, contracts, partnerships, and supply chains. * Review and provide compliance input on commercial contracts, ensuring adherence to regulatory requirements and company policies. * Conduct compliance assessments of product designs, data flows, and operational processes, identifying regulatory risks and developing risk mitigation strategies. * Contribute to building legal infrastructure: templates, playbooks, and internal tooling, including how we use Legora to operationalize legal work and collaborate across teams. * Develop and maintain privacy compliance programs, conduct data protection impact assessments, and ensure ongoing compliance with applicable data protection regulations; and * Establish efficient and scalable compliance frameworks and monitoring systems, developing compliance policies and guidelines that enable teams to proactively integrate regulatory requirements and compliance controls into products and processes. Who you are: * Law degree (LL.M. or equivalent) from Sweden, the UK, or an EU-jurisdiction, qualified to practice in that country. * Proficiency in spoken and written English. Additional language skills are meritorious. * 4+ years of experience at a top-tier law firm and/or as in-house counsel. * Proven expertise advising on GDPR, CCPA, and cross-border privacy compliance. * Familiarity with ISO standards and global compliance frameworks (e.g. AICPA SOC). * Strong experience negotiating B2B SaaS agreements and supporting commercial teams. You’re an excellent negotiator. * Strong legal judgment and confidence in making decisions independently * Highly organised, responsive, and solutions-oriented * Comfortable working across time zones in a global environment, and owning your priorities * Your focus is on achieving meaningful business outcomes, translating into actionable advice delivered clearly and comprehensively. * You thrive in a fast-paced, dynamic entrepreneurial environment and rapidly evolving business setting. You take initiative and are committed to delivering high-quality results. * You are excited about the potential of technology to transform the legal industry. You have a keen interest in AI and legal tech, and you are eager to learn and apply thesetools in real-world settings Legora is an Equal Opportunity Employer At Legora, we believe great teams are built on diversity of thought and experience. We’re proud to be an equal opportunity employer and committed to creating an inclusive, high-performance culture where everyone can do their best work. We welcome people of all backgrounds and don’t discriminate based on race, color, religion, national origin, gender, gender identity or expression, sexual orientation, age, disability, veteran status, or any other characteristic protected by law.

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Senior Director, GRA Development & Product Strategy Team Lead is responsible for the developing and implementing regulatory strategies, while leading people amd managing global projects. This role oversees a team of Global Regulatory Leads (GRL) supporting global products and may serve as a Regional Regulatory Lead (RRL) based on business needs. Essential Functions: •    Define and drive global regulatory strategies for all products within the assigned disease area, ensuring alignment with enterprise objectives and maximizing product value. •    Lead and develop a team of Global Regulatory Leads (GRLs), setting direction, building capabilities, and fostering a high-performance, accountable culture. •    Shape and integrate regulatory strategy into global product development and lifecycle plans in close partnership with cross-functional stakeholders. •    Oversee and ensure execution of regulatory strategies, including global submissions, approvals, and post-approval activities across assigned products and projects. •    Direct and represent the organization in interactions with health authorities, including leading negotiations and overseeing agency meeting strategy and execution. •    Guide and approve global regulatory submission plans, including marketing applications, labeling (e.g., CCDS), and key lifecycle deliverables. •    Manage and coordinate regulatory activities, timelines, and deliverables across internal teams and external partners, ensuring alignment and on-time execution. •    Ensure compliance with global regulatory requirements, internal policies, and GxP standards, including support for inspections, audits, and governance processes. •    Assess and communicate regulatory risks, emerging trends, and competitive intelligence, escalating issues and recommending mitigation strategies as appropriate. •    Drive operational excellence by leading process improvements, standardization efforts (e.g., SOPs/WIs), and adoption of best practices across Regulatory Affairs. •    Oversee external partnerships and due diligence activities, including vendor selection, alliance management, and regulatory support for business development transactions. •    Contribute to organizational leadership, including participation in RA Functional Teams (RAFTs), budget oversight, and fostering collaboration across Regulatory Affairs and the broader organization. •    Establish and maintain global labeling strategy, including oversight of Company Core Data Sheet (CCDS) development and alignment with regional labeling requirements. •    Allocate and optimize regulatory resources across the portfolio, ensuring effective prioritization and support for key business objectives. •    Recruit and build organizational capability by leading talent acquisition, succession planning, and ongoing training initiatives within the regulatory function. •    Ensure alignment with Vision 2030, company Core Values, Kabegoe Principles, and the Global Regulatory Affairs Vision. Requirements: Education Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline required.  Advanced degree (e.g., MS, PhD, PharmD, MBA) is preferred but not required; relevant industry experience may be considered in lieu of advanced education. Experience •    Minimum 12+ years extensive regulatory affairs experience within the pharmaceutical, biotechnology, or related industry, including global development and lifecycle management, with a focus on bone and mineral disease areas.  •    Proven leadership experience, including managing and developing high-performing regulatory teams and/or leading through other leaders (e.g., GRLs) •    Demonstrated success in developing and executing global regulatory strategies across multiple regions and product stages (development through post-approval) •    Significant experience interacting with health authorities, including leading regulatory agency meetings and negotiations •    Cross-functional leadership experience, with a strong track record of influencing stakeholders and driving alignment across complex, matrixed organizations •    Experience supporting business development activities, including regulatory due diligence for in-licensing, out-licensing, or partnerships Strong collaboration across cross-functional teams including regulatory affairs, government affairs, clinical, legal, and R&D. Technical Skills •    Deep knowledge of global regulatory frameworks and guidelines, including major markets (e.g., FDA, EMA, ICH,PMDA) and their application to drug development and lifecycle management •    Expertise in regulatory submissions and approvals, including INDs/CTAs, NDAs/BLAs/MAAs, and post-approval variations •    Strong understanding of global labeling requirements, including development and maintenance of Company Core Data Sheets (CCDS) •    Advanced regulatory strategy development and risk management skills, with the ability to anticipate challenges and drive solutions •    Familiarity with GxP requirements and regulatory compliance standards, including inspection and audit readiness •    Proficiency in regulatory systems, tools, and document management platforms used for submissions, tracking, and compliance •    Strong organizational and project management skills with the ability to manage multiple initiatives simultaneously. •    Exceptional communication and influencing skills, with the ability to clearly articulate complex regulatory strategies, risks, and requirements to diverse audiences, including health authorities, senior leadership, and cross-functional teams, to drive alignment and informed decision-making. •    Strong proficiency MS Office Suite. Working Conditions: Requires up to domestic and international travel. The anticipated salary for this position will be $265,000-$285,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton

About the position As a Global Regulatory Specialist, you will join our client's global Quality & Regulatory Affairs function and play a key role in ensuring that medical devices and mounting systems comply with regulatory requirements across international markets. You will become part of a central regulatory team based in Stockholm, supporting a global organization that operates in more than 80 countries and holds a market-leading position within assistive communication solutions. The role combines operational responsibilities with strategic influence. While maintaining existing regulatory processes, you will also support the organization by interpreting regulatory changes, providing expert guidance, and ensuring continued market access for the company's products. Key responsibilities: Maintain and improve technical documentation, including Annex II & III documentation and EU Declarations of Conformity. Coordinate product registrations and device listings with regulatory authorities, including the FDA, Authorized Representatives, and distributors. Support regulatory compliance activities related to EU MDR Class I products and FDA 510(k)-exempt Class II devices. Review device classifications and assess regulatory implications across global markets. Coordinate internal and external audits and support audit readiness activities. Monitor changes in global regulatory requirements and communicate their impact throughout the organization. Collaborate closely with Product Development, Quality, Operations, and other cross-functional teams to ensure regulatory compliance throughout the product lifecycle. This is a highly collaborative global role with frequent interaction with colleagues across Europe, North America, Asia, and Australia. While most collaboration takes place virtually, occasional international travel may occur, primarily within Europe. We are looking for someone whoHolds a Bachelor's degree in Regulatory Affairs, Life Sciences, Electrical Engineering, Electronics, or a related field. Has at least five years of experience working within Medical Device Regulatory Affairs. Has solid hands-on experience with EU MDR (Class I) and FDA Quality System Regulations (QSR). Has experience working with regulatory systems, document management tools, QMS platforms, technical documentation, and regulatory audits. Is comfortable interpreting complex regulatory requirements and translating them into practical guidance for different stakeholders. Communicates fluently in English, both verbally and in writing. Experience working with embedded systems, IEC 62304, EU MDR Class II/III products, or additional languages such as German is considered highly meritorious. We believe you areOur client place great emphasis on personal qualities, as success in this role depends on your ability to work collaboratively across a global organization while maintaining high regulatory standards. You are analytical, structured, and patient, with a genuine interest in understanding evolving regulations and staying up to date with industry developments. You enjoy reading, interpreting, and applying complex regulatory documentation and are comfortable working independently while supporting stakeholders throughout the business. You are confident in communicating regulatory requirements and able to influence others through facts and expertise. Rather than seeking a managerial position, you enjoy being the subject matter expert that colleagues rely on when navigating regulatory challenges. Curiosity and a willingness to continuously learn are highly valued, as regulations continue to evolve across global markets. About the partner company Our client is a global MedTech company headquartered in Stockholm and a world leader within assistive communication solutions. Every day, their products empower people with disabilities to communicate, connect with others, and live more independent lives. With approximately 1,400 employees worldwide, the company operates across multiple international markets and develops innovative medical devices used both in healthcare environments and at home. Their products hold a leading global market position, and regulatory compliance plays a critical role in ensuring continued market access across different regions. The Quality & Regulatory Affairs function is centrally located in Stockholm and collaborates closely with colleagues across Europe, North America, Asia, and Australia. You will join an experienced international organization where expertise, collaboration, and continuous learning are highly valued. About the employment This is a consulting assignment with employment through OIO. The assignment is expected to run for 6-12 months, with excellent opportunities for a permanent position with the client if both parties are satisfied. Scope: Full-time Start: August 2026 (for the right candidate, some flexibility is available) Location: Stockholm, Östermalm (hybrid, 1-3 days per week in the office) Working hours: Primarily office hours with flexible working arrangements Salary: Fixed monthly salary Apply today! Submit your application as soon as possible, as we review candidates continuously and the advertisement may close before the recruitment process is completed. About OIO Our passion is helping people find the right role and workplace. At the same time, we understand that choosing your next career move is an important decision. That's why we dedicate ourselves to getting to know both our candidates and their ambitions throughout the recruitment process. We believe that people have the greatest opportunity to reach their full potential when they're in the right environment. Through fair employment terms, close leadership, and continuous support, we actively contribute to your engagement and professional development. We are as picky as you are.

1 plats(er). Vill du vara med och främja människors hälsa och bidra till en hållbar miljö? Då är det dig vi söker! Miljö- och hälsoskyddsförvaltningen behöver nu en ny kollega till hälsoskyddsgruppen. Dina arbetsuppgifter Som miljö- och hälsoskyddsinspektör arbetar du med tillsyn enligt miljöbalken och utövar myndighetsuppdrag på ett respektfullt och sakligt sätt gentemot verksamheter och individer du möter ute på fältet. Den här tjänsten har inriktning mot hälsoskydd och innebär att du självständigt inspekterar verksamheter och bedömer om deras verksamhet uppfyller lagstiftningen. I rollen ställer du krav, informerar och fattar beslut, samtidigt som du bidrar till att skapa en hållbar och trygg miljö för alla. Du planerar och genomför tillsyn själv utifrån den beslutade tillsynsplanen samt driver dina egna ärenden från start till avslut. Som inspektör hos oss får du en varierande och utvecklande roll. Arbetet innebär många samarbetskontakter med andra aktörer, förvaltningar och privatpersoner vilket innebär att du behöver kunna kommunicera på ett anpassat och professionellt sätt. Dina arbetsuppgifter omfattar både planerad och händelsestyrd tillsyn. De tillsynsobjekt som är aktuella för tjänsten kan vara skolor, förskolor, skärande och stickande verksamheter med mera. Du kommer också handlägga inkommande ärenden som till exempel klagomål och anmälningsärenden. Du behöver på ett respektfullt sätt kunna informera, ställa krav och fatta beslut utifrån saklig grund. Du planerar din egen arbetsdag och driver dina ärenden både självständigt och i samverkan med andra. Du arbetar nära dina kollegor och ni ger och får stöd av varandra. Vi använder Ecos 2 som ärendehanteringssystem  Din kompetens Vi söker dig som har en högskoleutbildning om minst 180-240 hp från naturvetenskaplig, folkhälsovetenskaplig eller teknisk högskoleutbildning som bedöms lämplig alternativt motsvarande praktisk erfarenhet. Vi vill också att du har goda kunskaper i miljöbalken. Vi ser även att du har god datorvana och uttrycker dig väl i svenska både i tal och skrift. Har du utbildning i förvaltningsrätt på minst 15 högskolepoäng eller motsvarande praktisk erfarenhet ser vi det som ett plus. Erfarenhet av myndighetsutövning inom miljö- och hälsoskyddsområdet ser vi också som ett plus.  B-körkort är ett krav då tjänstebilar förekommer.  Som person är du trygg, stabil, lyhörd och kan behålla ditt lugn även i pressade situationer. Du har en god samarbetsförmåga och kommunicerar på ett konstruktivt sätt. Du tar ansvar för dina uppgifter och planerar samt organiserar ditt arbete på ett effektivt sätt. Du kan tänka riskbaserat och kritiskt samt har förmågan att anpassa dig efter nya rön och förändringar i lagstiftningen. Du kan uttrycka dig bra i tal och skrift på svenska, men det kan också hända att du behöver kommunicera på engelska. arbetet kräver mycket god datorvana” eller att det vävs in i befintlig text om kommunicering. Varmt välkommen med din ansökan! Vi erbjuder På miljö- och hälsoskyddsförvaltningen är vi cirka 50 personer som arbetar med tillsyn med stöd av bland annat miljöbalken, avfallslagstiftningen, kemikalielagstiftningen, strålskyddslagen, tobakslagen, alkohollagen, livsmedelslagen samt konsumentjuridisk rådgivning. Vi deltar i samhällsplaneringen genom exempelvis deltagande i interna styr- och projektgrupper och som remissinstans i planärenden. Vår verksamhet är utåtriktad och berör på något sätt alla som bor och verkar i Västerås. Vi som arbetar på miljö- och hälsoskyddsförvaltningen utför det operativa tillsynsarbetet som miljö- och konsumentnämnden ansvarar för. Här får du arbeta med engagerade och kompetenta kollegor som hjälper och är måna om varandra. Hos oss blir du en del av ett kompetent och engagerat team där samarbete och arbetsglädje står i centrum. Vi tror på frihet under ansvar, vilket innebär att du själv planerar och driver ditt arbete, samtidigt som vi värdesätter balans mellan arbete och fritid. Vi erbjuder därför flextid och möjlighet att arbeta hemifrån delar av veckan. Vårt kontor är centralt placerat med goda kommunikationsmöjligheter och vi har tjänstebilar och tjänstecyklar för resor i tjänsten. Dessutom erbjuds du även friskvårdsbidrag årligen. Läs gärna mer om förvaltningens arbete på: https://www.vasteras.se/miljoochhalsoskyddsforvaltningen Vi lever vår värdegrund i mötet med varandra och de vi är till för. Varje dag, året runt ser vi till att Västerås fungerar. Tillsammans med dina ca 11 500 kollegor runt om i staden får du Sveriges viktigaste jobb. Läs mer om möjligheter, karriärvägar och om vårt erbjudande här: https://www.vasteras.se/jobbochkarriär (https://www.vasteras.se/jobbochkarriär)   Övrig information I samband med intervju behöver du styrka ditt medborgarskap. Det kan du göra med pass alternativt personbevis tillsammans med ID-handling. Om du inte är medborgare i Sverige, EU, EES eller Schweiz måste du uppvisa att du har ett giltigt arbetstillstånd eller är undantagen från skyldigheten att ha arbetstillstånd. Anställning kan ske först efter kontroll av arbetstillstånd, vilket krävs enligt utlänningsförordningen. Alla erbjudanden om rekryterings- och annonseringshjälp undanbedes. Anställningsform: Tillsvidareanställning.

LINK Medical is searching for a highly motivated Principal Consultant Clinical Pharmacology & DMPK in Sweden (Stockholm, Uppsala or Lund), Denmark (Copenhagen) and Norway (Oslo). In this role, you will work in close collaboration with our local and international clients, being responsible for leading and managing Clinical Pharmacology and DMPK activities throughout the drug development lifecycle—ensuring scientific excellence, regulatory compliance, and efficient project delivery. Responsibilities · Provide expert scientific and regulatory guidance on clinical pharmacology, drug metabolism and pharmacokinetics (DMPK) aspects of drug development programs. · Lead and perform gap analyses and develop comprehensive clinical pharmacology development plans. · Conduct or oversee pharmacokinetic (PK) calculations, modelling, and analyses to support development decisions. · Monitor the implementation of clinical pharmacology and DMPK development plans and ensure timely follow-up. · Support clients in the selection, management, and coordination of activities with Contract Research Organizations (CROs). · Author or oversee the preparation of clinical pharmacology sections in regulatory documents such as IMPDs, NDAs, and MAAs. · Provide strategic input for regulatory interactions and submissions related to clinical pharmacology and DMPK. Desired qualifications · PhD in a relevant scientific field. · 5–10+ years of industry experience in clinical pharmacology and DMPK. · Experience across several drug classes such as small molecules, biologics, peptides, oligonucleotides, ATMPs, and/or vaccines. · Advantageous to have experience of modelling and simulation to support dosage selection, PKPD and/or population pharmacokinetic (popPK). · Experience of using WinNonlin software · Strong understanding of regulatory expectations within the relevant field. · Experience with global regulatory submissions such as IND, IMPD, etc. · Excellent communication and technical writing skills. · Proven project management experience with internal and external partners. · Proficiency in Microsoft Office applications. · Fluent in Swedish and English. Personal Characteristics · Proactive, collaborative, and scientific mindset. · Strong relationship-building and coordination skills. · Focusses on client needs, with strong communication and presentation skills. · Well-organized, able to work both independently and within teams. · Commercial awareness and negotiation ability. LINK Medical offers We offer an exciting and challenging position in a European CRO that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees in an international environment and values as honest and open communication are essential. You will be given meaningful tasks requiring efficient collaboration between industry, clinical and scientific teams, and the authorities. Besides a great working environment with dedicated and supporting colleagues, we also offer a competitive compensation, benefit scheme and great development opportunities for all employees. Contact Information If you would like to know more or if you have any questions about the position, please contact: Ulrika Andersson, Senior Director Drug Development, +46 76 492 4518, Ulrika.andersson@linkmedical.eu All applications are treated confidentially and will be evaluated when received, so please apply as soon as possible. Please submit your application in English. Last day for application: 31st of August, 2026.

RaySearch develops innovative software solutions to improve cancer care. About 1000 clinics in more than 40 countries use RaySearch software to improve treatments and quality of life for patients. RaySearch was founded in 2000 and is listed on Nasdaq Stockholm. The headquarters is located in Stockholm, with subsidiaries in the US, Europe and Asia - Pacific. Today we are more than 400 employees with a common vision of improving cancer care with innovative software. Our great staff is crucial for our success and we offer a fantastic working environment in modern offices, flexibility and good opportunities for development. We believe in equal opportunities, value diversity and work actively to prevent discrimination. Are you an experienced regulatory leader who enjoys developing people, improving processes, and driving regulatory excellence in a global medical device environment? Then this could be the right role for you.About the role We are looking for an experienced Regulatory Affairs Manager to lead a team of 5 Regulatory Affairs Specialists supporting our global medical device portfolio. This is a key leadership role for someone who combines deep global regulatory expertise with proven people leadership. You will lead and develop a team responsible for global regulatory submissions and registrations, regulatory compliance, vigilance, post-market regulatory activities, and regulatory intelligence. Success in this role requires a leader who is strategic, pragmatic, hands-on, and passionate about developing people while driving operational excellence.   What you'll do   Manage a team of 5 Regulatory Affairs Specialists.   Manage resource planning and allocation across global regulatory activities.   Ensure high-quality execution of global regulatory submissions, product registrations, and other regulatory operational activities.   Own and continuously improve core regulatory processes and ways of working.   Support global post-market regulatory activities, including vigilance, Post-Market Surveillance (PMS), Periodic Safety Update Reports (PSURs), regulatory compliance, and regulatory intelligence.   Provide technical guidance and hands-on support to the team on complex regulatory matters.   Foster a collaborative, engaged, and high-performing team focused on delivering regulatory excellence.  Your profile  You are an experienced regulatory leader with a passion for developing people, improving processes, and supporting a global medical device organization. You are a pragmatic and collaborative leader who translates regulatory requirements into practical, efficient processes that ensure compliance while supporting the business. You thrive in dynamic environments, focus on what matters most, build strong cross-functional relationships, and are motivated by developing talent and driving the continued success of the organization. Experience & skills  Extensive Regulatory Affairs experience within the medical device industry,   Proven people management experience, with the ability to lead, coach, and develop regulatory professionals.  Expert knowledge of the European Medical Device Regulation (EU MDR).   Demonstrated experience leading global regulatory submissions and product registrations, experience with at least one of the following regulatory authorities is required: China (NMPA), Japan (PMDA), India (CDSCO), US (FDA)   Experience with medical device software and IEC 62304.   Experience with medical device standards such as ISO 13485 and ISO 14971.  Strong understanding of global medical device regulations throughout the product lifecycle, including medical device product development and design control processes.  Demonstrated ability to optimize regulatory operations, improve processes, and lead teams through organizational change.   Excellent planning, prioritization, and stakeholder management skills.   A pragmatic, positive, and solution-oriented leader who leads by example, takes ownership, and thrives in a dynamic environment.   Proficiency in English.  Meriting experience  US regulatory experience, Experience with FDA submissions, including eSTAR/510(k).  Experience with IEC 62366 and ISO 14155  Experience with regulatory intelligence, regulatory signal monitoring, and evolving global regulatory requirements.   Experience with Cybersecurity requirements for medical devices.  Experience with AI/ML-enabled medical devices.  Our Culture Culture at RaySearch is the driving force behind our organization, where everything we do is driven by a shared passion for innovation and the fight against cancer. Our dedication is reflected in our ability to deliver exceptional results, pay close attention to detail, and consistently go the extra mile. Our employees stand out as experts in their field, driven by a relentless focus on solving problems - no matter how complex. At RaySearch, we take pride in leading the way in cancer treatment, leveraging cutting-edge technology to develop innovative solutions that make a real difference in patient care. Our Offer At RaySearch, we offer a diverse and inclusive work environment, fostering openness, sincerity, and collaboration. Located in Hagastaden, Stockholm's Life Science Hub, our modern and creative workspace includes an in-house gym, yoga, and social activities like ping pong, table football, and regular after-work events. Our bistro serves a fantastic lunch buffet, and we offer morning- and afternoon-fika every day. Our rooftop terrace also provides a stunning 360-degree view of Stockholm, enhancing the work experience. All of this comes attached with a competitive compensation and benefits package. Application Please apply to the position through the application form below. Selection and interviews will be ongoing. We do not accept applications by e-mail.

PolyPeptide is on a transformative growth journey – expanding globally, investing in new technologies, and increasing our production capacity through major site expansions and strategic projects. As part of this journey, we are launching a global SAP S/4HANA implementation and building a new ERP function from the ground up. We’re looking for an experienced IS/IT Compliance & Validation Specialist to help ensure that our new enterprise systems – especially the ERP platform – are implemented and maintained in line with industry standards, regulatory requirements, and best practices. This is a unique opportunity to join in the ERP journey and take a central role in securing validation of a modern, global ERP system in close collaboration with Global QA. About us PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre-clinical through to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide’s shares (SIX: PPGN) are listed on SIX Swiss Exchange. United by Purpose At PolyPeptide, we take pride in contributing to medicines that make a real difference to people's lives and health. Here, you will become part of work that truly matters, every single day. We are driven by our core values: trust, innovation and excellence. This is reflected in how we collaborate, solve problems, and uphold our responsibility for quality and safety for the patients ultimately affected by our work. We are a company undergoing rapid development. Our growth brings a fast-paced environment, change and new opportunities for both employees and the business. Here, you will grow together with us. If you are looking for a workplace where purpose, community and development go hand in hand, then PolyPeptide is the right place for you. About the Role In this role, you will be part of our global IS/IT organization and act as a key resource in securing regulatory compliance across enterprise systems – with a primary focus on the new ERP program. You’ll be responsible for system validation (CSV), audit readiness, change control, and risk management, with a strong emphasis on maintaining compliance with GxP, 21 CFR Part 11, EU Annex 11, and GAMP 5. You will work closely with Global QA, IT, regulatory affairs, and external vendors to ensure that the new ERP platform and other digital systems are inspection-ready, properly documented, and aligned with pharmaceutical regulations and expectations. Key Responsibilities * Develop and execute validation strategies for GxP-relevant systems in accordance with GAMP 5 and biotech/pharma industry standards. * Author and review validation documentation such as validation plans, IQ/OQ/PQ protocols, traceability matrices, and summary reports. * Ensure systems comply with electronic records and signature regulations (21 CFR Part 11, Annex 11). * Perform risk assessments for new systems, upgrades, and system changes, and integrate validation into the change management process. * Maintain audit-ready documentation and support both internal and external audits, including regulatory inspections. * Address audit findings and contribute to corrective and preventive actions (CAPAs). * Collaborate with QA, regulatory, manufacturing, and IT stakeholders as well as external vendors to align on compliance and validation requirements. * Provide training and guidance on validation procedures, regulatory expectations, and documentation standards. Your Profile We are looking for a structured and proactive specialist who thrives in a regulated environment and enjoys collaborating across functions. You bring: * A Bachelor’s or Master’s degree in Life Sciences, Engineering, Computer Science, or similar. * 5+ years of experience in IT compliance, system validation, or QA in biotech, pharma, or another regulated industry. * Solid knowledge of GxP, GAMP 5, 21 CFR Part 11, and EU Annex 11. * Experience with computerized system validation (CSV) and quality documentation. * Familiarity with enterprise platforms like ERP, MES, LIMS, or QMS. * Excellent analytical, documentation, and communication skills. * Full professional proficiency in English. As a person, you are detail-oriented and accountable – and you take pride in building systems and documentation that stand up to inspection and support safe, efficient operations. FIND THIS INTERESTING? APPLY NOW! Are you ready to take the next step in your career? The position will be open until August 31 but we are applying ongoing selection so do not hesitate to send us your application. Due to summer vacation we will start going through the applications later in August. For more information, please contact Krister Svärd at krister.svard@polypeptide.com. Swedish applicants are welcome to contact the local union chairman for Akademikerföreningen or Unionen at +46 040-36 62 00 for support.

Vi söker nu en Product Compliance Lead som vill driva och utveckla Synsams arbete inom product compliance och vägleda organisationen i hur krav omsätts i praktiken. Detta är en nyckelroll där du verkar som PRRC för våra egna varumärken och säkerställer att de uppfyller alla relevanta regulatoriska krav. Rollen omfattar även rådgivning och stöd inom compliance för vårt övriga sortiment. Om rollen Rollen kombinerar strategiskt ansvar med ett operativt arbetssätt. Du arbetar nära produktutveckling, kategori, inköp, produktion och leverantörer för att säkerställa att krav implementeras i praktiken, från design och materialval till testning och slutligen en färdig produkt. Rollen i sin helhet är dessutom ny inom Synsam, vilket ger dig möjligheten att fortsätta forma arbetssätt och struktur över tid. Dina ansvarsområden * Säkerställa global efterlevnad av produktrelaterade regelverk och standarder för Synsams varumärken (t.ex. MDR, PPE, ISO) * Säkerställa korrekt produktklassificering, teknisk dokumentation, CE-märkning och marknadsspecifik övrig dokumentation * Ansvara för att Synsam följer produktrelaterade lagar och regler såsom kemikalieefterlevnad och materialkrav globalt (REACH, SVHC m.m.) * Koordinera och kvalitetssäkra testning via ackrediterade laboratorier * Stödja produktutveckling i frågor avseende product compliance från design till lansering * Löpande bevaka och implementera förändringar i globala lagstiftningar och standarder * Ansvara för budget och kostnadsuppföljning kopplat till efterlevnad av ISO-standarder, regulatoriska krav och kemikaliekontroller Vem är du? Du har god kunskap inom product compliance, med förmåga att självständigt driva och utveckla området i en verksamhet. Du har en stark förståelse för hur regulatoriska krav omsätts till effektiva och fungerande arbetssätt genom hela värdekedjan samtidigt som du har ett starkt operativt driv och är van att själv arbeta hands-on i detaljerna. Du är trygg i din kompetens och van att ta ägarskap för komplexa frågeställningar, fatta beslut och sätta struktur där den saknas. Som person ser vi gärna att du har ett pragmatiskt och affärsnära förhållningssätt och bidrar med en energi som för arbetet framåt. Vi söker dig som * Uppfyller kraven för att vara PRRC (Person Responsible for Regulatory Compliance) enligt EU MDR, vilket innebär att du har: * Examensbevis, certifikat eller annat behörighetsbevis efter fullbordad högskoleutbildning inom juridik, medicin, farmaci, ingenjörsvetenskap eller någon annan relevant vetenskaplig disciplin. Du behöver även ha minst ett års yrkeserfarenhet av regleringsfrågor eller kvalitetsledningssystem på området för medicintekniska produkter (extra meriterande inom glasögonbågar/konsumentartiklar) * Alternativt fyra års yrkeserfarenhet av regleringsfrågor eller kvalitetsledningssystem på området för medicintekniska produkter. * Erfarenhet av att självständigt ansvara för product compliance inom tillverkande industri eller konsumentprodukter * Dokumenterad erfarenhet av att bygga upp, strukturera eller utveckla processer inom compliance * Mycket god förmåga att kommunicera på svenska och engelska Vi ser även gärna att du har * Erfarenhet av kemikalie- och materialefterlevnad (t.ex. REACH, SVHC, metaller, restriktioner) * Erfarenhet av att driva testning och verifiering, inklusive arbete med externa laboratorier Det är också meriterande om du har erfarenhet av arbete med leverantörer i Asien samt ISO-standarder och kvalitetsledningssystem. Om tjänsten Tjänsten är en tillsvidareanställning med inledande provanställning på sex månader och start enligt överenskommelse. Du rapporterar till Chief Sustainability Officer, Yordabelle Nordström. Du utgår från huvudkontoret på Kungsholmen, Stockholm med frekventa resor till vårt Innovationscenter på Frösön (Östersund). Om rekryteringsprocessen I vår rekryteringsprocess ingår tester, intervjuer samt referenstagning och bakgrundskontroll för slutkandidat. Intervjuer för tjänsten kommer att hållas i mitten på augusti men vi ser gärna att du söker redan idag. Vi på Synsam söker engagerade och talangfulla personer i alla åldrar! Hos oss värdesätts mångfald och vi tror att olika perspektiv och erfarenheter berikar vårt arbete och bidrar till vår gemensamma framgång.

Join our client, a leader in automotive compliance and technical documentation, on an innovative project quality-assuring AI-translated owner's manuals for passenger cars, ensuring international market standards and regulatory compliance. About the role This role involves critically assessing and refining AI-translated owner's manuals and technical documents for passenger cars. You will play a crucial part in quality assurance, ensuring linguistic accuracy, natural tone, and strict adherence to local language requirements and international compliance standards. Starting with an initial manual and extending to further material up to about 700 pages. The assignment can be executed fully remote during flexible working hours but needs to be completed before/during the summer. You will need to have access to a computer with a license for Office 365 and WiFi. Work tasks Quality assurance and linguistic refinement of AI-translated technical documentation and owner's manuals for the automotive sector, ensuring compliance with international and local standards. Review AI-translated technical material for automotive owner's manuals. Verify language, tone, and formulations to ensure natural and accurate text. Implement linguistic adjustments and improvements. Ensure content adheres to local language requirements and industry standards. Identify and address deficiencies in manuals to meet EU compliance. We are looking for Access to a computer with the Office 365 suite. Advanced fluency in one of the following languages: Dutch, German, French, Danish, Norwegian, Romanian, Slovenian, Croatian, Greek, Portuguese, Polish, Czech, Serbian, Slovak, Estonian, Latvian, Hungarian. Advanced reading comprehension and meticulous attention to detail. Good knowledge of technical documentation principles. Fluent in English. It is meritorious if you have Experience with reviewing AI-translated content. Understanding of compliance and certification processes. Familiarity with the automotive industry or technical texts. Experience working with Adobe tools for linguistic review. To succeed in the role, your personal skills are: Goal oriented Orderly Responsible Our recruitment process This recruitment process is handled by Academic Work and it is our client’s wish that all questions regarding the position is directed to Academic Work. Our selection process is continuous and the advert may close before the recruitment process is completed if we have moved forward to the next phase. The process includes two tests: one personality test and one cognitive test. The tests are tools to find the right talent for the right position, to enable equality, diversity, and a fair process. To join us in a part-time role, you’ll need another main activity that covers at least 50% of your time. That could be studies, another job, running your own business, parental leave, or something similar.

Interim Responsible Value Chain Manager Are you a senior consultant with experience in due diligence, compliance and responsible value chains within metals and minerals? Would you like to contribute specialist expertise in an international industrial company where responsible business conduct, business ethics and regulatory compliance are business-critical matters? The role On behalf of our client Boliden, we are looking for an experienced Responsible Value Chain Manager for a one-year assignment. Strategically important and plays a central role in ensuring continuity, quality and regulatory compliance in Boliden’s work with due diligence and responsible business conduct in the global metals and minerals value chain. The role is placed within the sustainability function and reports to the Sustainability Manager. You will be part of a specialist team with senior expertise in environment, product responsibility, sustainability governance etc. The role also has an important interface with senior management, including reporting on business partner evaluations and the progress and results of the program. About the assignment The assignment will start in October and run for one year. The preferred location is Stockholm. The role involves recurring international travel to conduct on-site assessments and meet current and potential business partners. You will drive and follow up Boliden’s Responsible Value Chain Program, including due diligence of partners in the global metals and minerals value chain. You will ensure that risk-based and impact-driven due diligence is integrated into business decision-making and that the work meets internal requirements, industry standards and an evolving regulatory landscape. You will act as a senior advisor to commercial and functional teams, strengthen organisational capability and exercise independent judgement in complex matters related to compliance, ethics, human rights and relevant areas. The role also involves leading cross-functional delivery, translating requirements into processes, and contributing to clear governance and consistent execution.. Examples of responsibilities: ·         Drive and follow up Boliden’s Responsible Value Chain Program and due diligence work for business partners in the global metals and minerals value chain. ·         Identify, assess and contribute to mitigating risks related to business partners, within compliance, business ethics, human rights, labour conditions, environment and responsible business conduct. ·         Conduct and quality-assure risk assessments, partner evaluations and on-site assessments. ·         Ensure compliance with internal requirements, standards and legislation within due diligence and responsible sourcing. ·         Support, train and advise raw material sourcing- and sales managers. ·         Lead cross-functional groups and coordinate activities between commercial, legal, compliance and sustainability functions. ·         Contribute to clear reporting, documentation and follow-up of program implementation to decision-making forums and senior management. Who are we looking for? ·         Academic degree, in law, business administration, social sciences, compliance or equivalent. ·         Solid experience of due diligence, compliance, responsible sourcing, business ethics or responsible business conduct. ·         Experience of risk identification, risk assessment and risk mitigation related to business partners in international value chains. ·         Good understanding of value chains within metals, minerals or another relevant sector. ·         Excellent ability to communicate clearly, build trust and influence a broad range of stakeholders. ·         Strong analytical skills, high integrity and ability to make independent judgements in complex matters. ·         Documented high quality in delivery, structure and follow-up. ·         Fluent English, both spoken and written. Meritorious: ·         Experience from the mining, metals, raw materials or process industry. ·         Experience of responsible sourcing standards and industry requirements in the mining and metals industry, JDDS, LBMA, LPPM, LME Responsible Sourcing Requirements or Copper Mark. ·         Knowledge of the OECD Guidelines for Multinational Enterprises, the OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas, and relevant or upcoming legislation such as CSDDD and the EU Conflict Minerals Regulation. ·         Legal background or another clear compliance profile. ·         Spanish or Portuguese language skills. Application Sound interesting? Please submit your application in the form of a CV. For more information, please contact Linus Elghorn, linus.elghorn@hrmab.se. About Boliden Boliden is an international metals company with a clear ambition to be a responsible actor throughout the value chain. The company’s values — Care, Courage and Responsibility — guide how Boliden works with business partners, internal collaboration and long-term responsibility. In this role, this means acting with integrity, clarity and professional judgement in matters that are important to both the business and society.

Founded in 1986 by Karl Leif Torbjörn Marklund in Kumla, Sweden, Legosan AB has been a trusted partner in contract manufacturing for four decades. Initially focused on dietary supplements, we expanded into pharmaceuticals in 1998, becoming an authorized manufacturer of medicinal products. ​ Today, as part of the Wellma Group (https://www.wellma.com/), we offer a full range of custom manufacturing services tailored to meet the specific needs of each client. ​ Our modern facility is GMP-certified under EU regulations and licensed by the Swedish Medical Products Agency (Läkemedelsverket) for the manufacture of medicinal products. ​ For dietary supplements and food-grade products, we operate in compliance with HACCP requirements and hold certifications to internationally recognized quality standards, including IFS Food — a GFSI-recognized scheme developed by European retailers — and NSF/ANSI 455-2 GMP, considered the gold standard for dietary supplement manufacturing in North America. ​ At Legosan AB, we are committed to quality, regulatory compliance, and environmentally responsible practices — delivering reliable, high-quality manufacturing solutions that meet the evolving needs of our clients. Legosan befinner sig i en spännande utvecklingsfas och söker nu ytterligare en Qualified Person (QP) som vill vara med och vidareutveckla företagets kvalitetsarbete. Här erbjuds du en nyckelroll i en verksamhet där du får stort inflytande, korta beslutsvägar och möjlighet att vara med och påverka både arbetssätt och processer. Varmt välkommen med din ansökan! Information om tjänsten Professionals Nord söker i samarbete med Legosan en Qualified Person (QP). Legosan är ett svenskt företag som utvecklar och tillverkar kosttillskott och läkemedel med höga kvalitetskrav och ett starkt fokus på långsiktighet, kvalitet och kundnytta. Tjänsten är en direktrekrytering vilket innebär att rekryteringsprocessen sker genom Professionals Nord och att du anställs direkt hos Legosan. Du erbjuds En nyckelroll med stort ansvar och möjlighet att påverka verksamheten Möjlighet att utveckla och förbättra kvalitetsprocesser i en växande organisation En verksamhetsnära roll med korta beslutsvägar Ett bolag med hög kompetens, stark kvalitetskultur och engagerade kollegor Möjlighet att växa tillsammans med verksamheten och på sikt utveckla team och ansvar Arbetsuppgifter Som QP har du det övergripande ansvaret för att säkerställa att verksamheten uppfyller gällande kvalitets- och myndighetskrav. Rollen innebär ett nära samarbete med flera delar av organisationen och ett aktivt arbete med att utveckla och säkerställa effektiva kvalitetsprocesser. Dina huvudsakliga arbetsuppgifter innefattar: Ansvara för och säkerställa GMP-efterlevnad Granskning och frisläppning av batchdokumentation Underhåll och vidareutveckling av företagets kvalitetssystem Hantering av avvikelser, CAPA och förändringsärenden Planering, genomförande och uppföljning av interna och externa revisioner Framtagning och uppdatering av styrande dokument, rutiner och processer Vara ett kvalificerat stöd till organisationen i kvalitets- och regulatoriska frågor Vi söker dig som Har en relevant akademisk utbildning inom farmaci, kemi, kemiteknik eller annat naturvetenskapligt område som uppfyller kraven för att verka som Qualified Person Har erfarenhet från läkemedelsindustrin och arbete i GMP-reglerad verksamhet Har erfarenhet av kvalitetsarbete, QA, validering och produktion.  Har mycket god förståelse för regulatoriska krav och kvalitetssystem Kommunicerar obehindrat på svenska och engelska i tal och skrift Det är meriterande om du har tidigare erfarenhet av arbete som QP eller batchfrisläppning, men vi välkomnar även dig som har rätt utbildningsbakgrund och erfarenhet för att utvecklas in i rollen. Personliga egenskaper Vi tror att dina personliga egenskaper är avgörande för hur väl du kommer att trivas hos Legosan. För att lyckas i rollen ser vi att du är en strukturerad och kvalitetsmedveten person som trivs med ansvar och självständigt arbete. Du har ett prestigelöst förhållningssätt, tycker om att samarbeta med andra och motiveras av att skapa ordning, kvalitet och långsiktiga förbättringar. Vidare är du lösningsorienterad, noggrann och trygg i att fatta beslut i frågor som rör kvalitet och regelefterlevnad. START: Enligt överenskommelse OMFATTNING: Heltid STAD: Kumla URVAL: Sker löpande KONTAKT: Professionals Nord

About Norvion Systems AB Norvion Systems AB, headquartered in Gothenburg, Sweden, is an innovative engineering company delivering advanced AI, robotics, embedded systems, and automotive engineering solutions across the Nordic region and Europe. We work closely with leading industrial partners to support the development and deployment of next-generation technologies. Our engineering teams combine deep industry experience with a practical Nordic engineering culture focused on innovation, quality, and real-world impact. To support one of our automotive partners in Gothenburg, we are looking for an experienced Product Cybersecurity Officer to join a long-term consulting assignment. If you have experience in automotive cybersecurity, regulatory compliance, and product security governance, we would love to hear from you. About the Assignment As a Product Cybersecurity Officer, you will support product cybersecurity activities throughout the development lifecycle, ensuring compliance with automotive cybersecurity regulations and standards. You will work closely with cross-functional teams and stakeholders to coordinate cybersecurity activities, support compliance efforts, and contribute to secure product development. Key Responsibilities Support product cybersecurity activities for automotive projects Ensure compliance with automotive cybersecurity regulations and standards Coordinate cybersecurity-related activities across cross-functional teams Support regulatory compliance, audits, and certification activities Collaborate with engineering teams and stakeholders throughout the product development lifecycle We Are Looking For We are looking for professionals with experience in automotive product cybersecurity and regulatory compliance. You should have: Experience in Automotive Cybersecurity (CSMS, UN R155, ISO 21434) Knowledge of Automotive E/E Architecture and ECUs Experience with regulatory compliance, audits, and certification Strong stakeholder management and program coordination skills Fluent English communication skills Advantageous Experience The following experience will be considered a strong advantage: Swedish language skills Korean and/or Chinese language skills Experience with vehicle connectivity and off-board cybersecurity Assignment Details 📍 Location: Gothenburg, Sweden (On-site) 📅 Start Date: 10 August 2026 📄 Duration: Until 27 August 2027 Application Deadline: 30 July 2026 Due to the very short onboarding timeline, only candidates who already have the legal right to work in Sweden (Swedish/EU citizenship, Permanent Residence, or a valid Swedish work permit) can be considered for this assignment. Why Join Norvion? Engineering Beyond Boundaries At Norvion, engineers work on real industrial challenges involving advanced automotive technologies, AI, robotics, and intelligent systems. Work With Experienced Engineers Join a team with strong European engineering experience and collaborate with experts from leading technology companies and automotive organizations. Nordic Engineering Culture We believe in: Flat communication Technical excellence Individual ownership Continuous learning Sustainable work-life balance Interested? Please send your English CV to: 📧 hr@norviontech.com

Bohus Biotech is an innovative company focused on the development and manufacture of high-quality products containing hyaluronic acid (HA). We are now in an expansive phase, investing in the products and processes of the future. We are looking for a driven Process Engineer who wants to become part of Bohus’s future and contribute to the continued development of hyaluronic acid and its products. As our Process Engineer, you will be responsible for developing, optimizing, validating, and maintaining manufacturing processes to ensure product quality, process robustness, regulatory compliance, and operational efficiency. The role supports both existing production processes and the introduction of new products and technologies. You will be working closely with dedicated and highly competent colleagues within Production, Quality Assurance, Regulatory Affairs, Supply Chain, and R&D. You will get the exciting opportunity to build, shape and optimize our processes and apply your experience and expertise to ensure the highest manufacturing standards. If this sounds interesting to you - Come join us! This is a full-time position and based in our company location in Strömstad, Sweden. On-site in Strömstad preferred, but hybrid solutions are possible for the right candidate. We will interview candidates continuously and welcome your application today. Key responsibilities The Process Engineer is responsible for ensuring that manufacturing processes are robust, efficient, validated, and compliant throughout the product lifecycle. You will bridge day-to-day manufacturing support with longer-term process development and operational excellence initiatives. The position reports to the COO. Duties and responsibilities include: Develop, implement, and continuously improve manufacturing processes to enhance quality, yield, and efficiency. Lead root cause investigations and implement corrective and preventive actions (CAPA). Plan, execute, and document validation activities, including Process Validation, Equipment Qualification (IQ/OQ/PQ), Cleaning Validation, and Test Method Validation/Verification. Provide technical support to production, investigating process deviations, non-conformities, and out-of-specification results. Lead continuous improvement initiatives using structured problem-solving methods such as Root Cause Analysis, FMEA, and 5 Why. Ensure processes comply with ISO 13485, EU MDR 2017/745, ISO 14971, and GMP principles. Support audits and inspections by customers, regulatory authorities, and Notified Bodies. Support technology transfers from R&D to production and participate in cross-functional development projects. Approve process validation documentation according to delegated authority and escalate process risks impacting product quality, compliance, or supply. Skills and Competencies The suitable candidate has the following qualifications: Formal academic degree level (BSc. or MSc.) in chemical engineering, biotechnology, pharmaceutical science or related. Strong background in process engineering preferably combined with validation engineering experience. Experience working in a manufacturing environment within a regulated industry (e.g. Medical Devices, Pharmaceuticals, Biotechnology, or other regulated industries). Experience with process optimization, process validation and problem solving. Experience with sterile processes, equipment qualification (IQ, OQ, PQ), process validation, troubleshooting, and continuous improvement would be highly valuable. Experience working with Quality Management Systems. Knowledge of statistical analysis and process capability concepts. Excellent communication and documentation skills in English are required The successful candidate for this position will be someone who: Has a strong technical and analytical mindset. Enjoys solving complex manufacturing and process-related challenges. Is structured and detail-oriented. Takes ownership and drives improvements independently. Communicates effectively across departments and organizational levels. Combines hands-on problem solving with a systematic approach. Thrives in a fast-paced environment where quality, compliance, and operational performance are equally important. We offer a dynamic working environment with significant opportunity to make an impact — contributing to Bohus’s success as well as your own growth and development. About Bohus Biotech Founded in 1993, BOHUS has been at the forefront of Hyaluronic Acid (HA) development and manufacturing for over three decades. Our journey began with a vision to revolutionize the HA industry through innovation and commitment to excellence. With more than 30 years of expertise, the company has established a strong international presence with products distributed to hospitals, clinics, and physicians in over 60 countries worldwide. Bohus Biotech focuses exclusively on high quality hyaluronic acid technologies across three therapeutic areas: Ophthalmology – OVD solutions supporting tissue protection during cataract surgery Aesthetics – Dermal fillers based on the proprietary SHAPE™ technology platform Orthopaedics – Injectable treatments for osteoarthritis All research, development, and manufacturing are located in Strömstad, Sweden, ensuring full control over product quality and innovation. For more information, visit the company's web sites at: www.bohusbiotech.com For more information about this position, please contact: Krishan Johansson Haque, PhD Sr Recruitment Consultant, QRIOS Life Science & Engineering T: +46 (0)72-070 16 53 E: krishan.johansson-haque@qrios.se

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across clinical trials. This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions. The role partners cross-functionally to embed risk-based decision-making into study design, execution, oversight, and continuous improvement, in alignment with ICH E6 (R3), GCP, and global regulatory expectations. Essential Functions: Risk-Based Quality Management (RBQM) Leadership •    Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance. •    Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors. •    Integrate RBQM principles into study planning, execution, oversight, and close-out activities. •    Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy. Central Risk Identification, Monitoring & Mitigation •    Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks. •    Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials. •    Oversee centralized risk monitoring and trending to enable early detection of critical risks. •    Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons  Learned & Risk Library Management (Core Ownership) •    Establish and maintain a centralized Clinical Risk Library, capturing: o    Known and emerging risks o    Root causes o    Mitigation strategies o    Effectiveness of controls •    Lead lessons learned activities across trials, audits, inspections, and CAPAs. •    Ensure lessons learned are: o    Systematically captured o    Analyzed for trends o    Fed back into RBQM planning, SOPs, training, and future studies •    Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.readiness. Quality Oversight & Regulatory Compliance •    Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs. •    Provide centralized quality oversight across trials, CROs, and vendors. •    Support audit and inspection readiness activities, including: o    Risk-based inspection preparation o    Impact assessments o    CAPA development and effectiveness checks Vendor & CRO Risk Oversight •    Design and implement risk-based oversight strategies for CROs and external vendors. •    Monitor vendor performance using quality metrics and risk indicators. •    Lead or support quality governance discussions with external partners. •    Ensure vendor-related risks are integrated into the central risk library and lessons learned framework. Data-Driven Quality & Continuous Improvement •    Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making. •    Generate enterprise-level risk trend reports and insights for senior leadership. •    Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned. •    Champion a culture of proactive quality and continuous improvement across Clinical Operations. Cross-Functional Collaboration & RBQM Expertise •    Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance. •    Provide RBQM training and coaching to study teams and cross-functional stakeholders. •    Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics. •    Participate as an observing member on assigned study teams to provide real-time quality and risk support. SOP Management & Governance Support •    Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates. •    Support governance activities, senior management reporting, and quality metrics standardization. •    Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.provide real-time quality and risk support. Requirements: Education •    Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required) •    Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred) Experience •    10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM •    Demonstrated experience leading enterprise or cross-study risk management frameworks •    Strong background in audit/inspection readiness, CAPA management, and vendor oversight •    Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements Technical Skills •    Expertise with RBQM tools, centralized monitoring systems, and risk analytics •    Experience defining and using KRIs, QTLs, and quality metrics •    Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI) •    Exposure to AI or predictive analytics for quality monitoring (preferred) Working Conditions: Requires up to 25% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines. The anticipated salary for this position will be $175,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton