Search results for "FDA Audit"

SallyQ AB

The role We call ourselves a 60-year-old startup. Decades of scientific heritage, paired with the speed, ambition and hands-on energy of a company being built from the ground up. Right now, we're scaling manufacturing fast, and that means the way we assure sterility needs to scale with it. We're looking for a Sterility Assurance Lead who wants to own that agenda from day one, not just maintain a system, but shape how sterility assurance grows alongside the site. You will own and drive the site’s sterility assurance strategy. This role ensures compliance with global regulatory requirements and serves as the SME for contamination control, aseptic processing, and sterilization validation. Key Responsibilities Lead the Sterility Assurance Program (SAP) and Contamination Control Strategy (CCS) in line with EU GMP Annex 1 and global standards. Oversee environmental monitoring, cleanroom qualification, and aseptic practices. Review sterilization validations and lead media fill programs. Drive contamination risk assessments, investigations, and CAPAs. Act as SME during audits and inspections. Provide training and mentorship in sterility assurance best practices. The role is based at Galderma's production site in Uppsala and requires on-site presence up to four days per week. Your Profile You are a highly motivated sterility assurance professional with a strong quality mindset and a passion for patient safety. You combine deep technical expertise with leadership capabilities and are comfortable acting as a site Subject Matter Expert. You're energized rather than unsettled by a fast-scaling environment, you bring a proactive, solution-oriented approach that lets you spot risks early, drive improvements, and push operational excellence forward even as priorities shift. You thrive in a collaborative, cross-functional environment and can communicate complex technical topics clearly to both technical and non-technical stakeholders. You're confident leading investigations, mentoring colleagues, and driving initiatives that strengthen contamination control and aseptic manufacturing performance, and you see this growth phase as a chance to grow your own scope right along with it. Requirements Bachelor's or Master's degree in Microbiology, Biotechnology, Pharmacy, or another relevant life science discipline. 8–12 years of experience in sterile manufacturing, microbiology, or sterility assurance within the pharmaceutical, biologics, or medical device industry. Proven experience working in GMP-regulated environments and supporting regulatory inspections and audits. Hands-on experience with contamination control strategies, environmental monitoring programs, and aseptic manufacturing operations. Skills Deep technical expertise in aseptic processing, sterilization technologies (moist heat, dry heat, filtration), and microbial contamination control. Strong knowledge of cleanroom operations, HVAC qualification, isolators/RABS, and environmental monitoring systems. Solid understanding of EU GMP Annex 1 requirements and familiarity with global regulatory expectations (FDA, EMA, PIC/S). Experience performing risk assessments using tools such as FMEA, HACCP, or similar methodologies. Strong analytical mindset with the ability to interpret data trends and drive continuous improvement initiatives. Excellent documentation skills and a structured approach to problem-solving and investigations. Strong communication and collaboration skills with the ability to influence cross-functional teams. Application If you believe this can be a right career change for you, please send in an application as soon as possible. We are evaluating the application continuously so please do not wait to send in your application. About Galderma Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

RaySearch Laboratories AB (publ)

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 a driven regulatory professional who enjoys ownership, collaboration and working close to product development? This could be the role for you. Apply and help shape the future of medical device software at RaySearch.About the role  We are looking for an experienced and driven Regulatory Lead to own the regulatory strategy and lifecycle oversight for one of RaySearch's products. In this role, you will be the regulatory point of contact for the product, working closely with key stakeholders in the Development, Corporate Strategy and Sales teams. You will help shape product strategy, guide development activities, drive market access, and ensure compliance throughout the product lifecycle.  This is a highly visible role for someone who enjoys combining deep regulatory expertise with strategic thinking, project coordination, and collaboration across the organization.  What you'll do  Own and drive the global regulatory strategy for your product throughout its lifecycle.  Lead the preparation, review, and maintenance of Technical Documentation and regulatory submissions, including EU MDR.  Act as the regulatory expert within development projects and ensure regulatory requirements are integrated throughout the design and development process.  Coordinate and oversee multiple projects, priorities, and submission timelines while maintaining a long-term view of the product roadmap.  Partner closely with Development, Corporate Strategy, Sales and other key stakeholders to support product development and market access.  Support inspections, audits, post-market activities, and continuous improvements.  Your profile  You are a proactive and pragmatic regulatory professional who enjoys taking ownership and driving things forward. You are technically strong, comfortable working with development teams, and able to translate complex regulatory requirements into practical solutions.  You like having oversight of the full product picture—from early development and regulatory strategy to submission and post-market activities—and you thrive in a collaborative, fast-paced environment where you can make a real impact.  Requirements  Bachelor's or Master's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.  Several years of Regulatory Affairs experience within the medical device industry.  Strong experience preparing and reviewing Technical Documentation under EU MDR.  Experience working with medical device product development and design control processes.  Experience with medical device software  Strong knowledge of IEC 62304, IEC 60601 and ISO 14971  Strong project management and stakeholder management skills.  Ability to manage multiple activities and timelines while maintaining the bigger picture.  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 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.

OIO Väst AB

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.

Celsus Engineering AB

About the Role As a Global Regulatory Specialist, you will join our Quality & Regulatory Affairs team to help ensure our medical devices and mounting systems meet global regulatory requirements. Please note: This is a hybrid role with 1–3 days per week onsite at our Stockholm office in Östermalm, especially during onboarding. Occasional international travel (10–20%) may be required and will be communicated in advance. In this role you will: Streamline regulatory processes and set a roadmap in collaboration Product & Development, QA, and Operations teams. Coordinate with internal and external auditors to support audit readiness. Review device classifications and regulatory challenges across markets. Maintain and update technical documentation (Annex II & III) and declarations of conformity, including EU Declaration of Conformity, in alignment with the associated technical documentation. Coordinate establishment of registrations and device listings with the FDA, Authorized Representatives, and Importers/Distributors. Support product registrations and market access activities (EU MDR Class I, FDA 510(k)-exempt Class II). Monitor regulatory changes and communicate implications to relevant teams. What We’re Looking For We are looking for a structured and collaborative regulatory professional who enjoys solving problems with a logical approach, works autonomously while contributing to strategic initiatives, and thrives in a dynamic, cross-functional environment. We’re looking for a detail-oriented and analytical professional with: A bachelor’s degree in Regulatory Affairs, Life Sciences, Electrical-Electronics or a related field. At least 5 years of experience in medical device regulatory affairs with hands-on experience with EU MDR (Class I) and FDA QSR. Experience with regulatory systems, document control tools, and QMS platforms and exposure to technical documentation, internal and external audits for regulatory compliance Strong organization, coordination and communication skills to engage auditors and communicating with stakeholders across functions and levels. Ability to break down complex regulatory topics clearly for both technical and non-technical stakeholders. Proficiency in both spoken and written communication in English. Ideal candidates will bring: Familiarity with embedded systems and experience with IEC 62304. Experience with EU MDR (Class II/III).

Vitrolife

At the Vitrolife Group, we work every day to unlock the full potential of science and technology to reduce the barriers towards building a family. Together we help our customers and their patients to fulfil the dream of having a baby. We are seaking for a skilled Project manager New Product Role overview Are you ready to lead the next chapter of our innovation projects? As Project Manager New Product Introduction (Genetics) at Vitrolife Group, you will drive end-to-end strategic projects execution coordinating activities all the way from research to product launch. You will work across cross-functional, multinational teams to translate science into impactful products, ensuring full alignment with regulatory frameworks, technical and business objectives. Join us and be part of the vision: Enable people to fulfil their dream of having a healthy baby. Reporting to the Strategy & Sustainability Area, you will be based in Valencia. Your Key Responsibilities Own the full project lifecycle of new product introduction projects in the Genetics area: from concept and design through development, validation, regulatory submission, and commercial launch, ensuring delivery on time, within scope and budget. Lead cross-functional and multi-site project teams across geographies, coordinating with R&D, Market Access, Quality, Operations, Product Management, Marketing and other relevant stakeholders. Manage senior stakeholder and sponsor-level relationships, providing transparent reporting on project status, risks, and decisions through structured governance frameworks. Apply stage-gate methodologies to drive targeted innovation. Having a good understanding of the design review processes, connecting at every moment technical and business decisions. What You Bring At Vitrolife Group, our core values - Integrity, Quality, Innovation, and Collaboration – guide us in everything we do. Together with also being a pro-active, analytical and strategic problem-solver, with experience from cross-functional collaboration, you bring: Education BSc + MSc in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, or a closely related field (required). Additional management or business education (MBA or equivalent) is a plus. Experience 4–6 years of hands-on experience in clinical or innovation project management within a global life sciences, IVD, medtech, or biotech organisation. Demonstrated full project lifecycle ownership: from early-stage innovation through technical development, regulatory submission, and market introduction. Proven track record in senior stakeholder and sponsor-level management across complex, matrixed organisations. Experience in IVD/MDR regulated development environments; regulatory pathways (MDR/IVDR, FDA 510(k), De Novo, CLSI guidelines, LDTs). Budget accountability and expertise on status, resource & expenditure tracking in PPM tools and Power BI. Direct experience applying stage-gated processes in product development & market introduction cycles, including design reviews and cross-functional milestone governance. Multi-site, multinational project coordination experience. Skills & Certifications Strong command of project governance frameworks and risk management methodologies. Excellent communication skills in English. Proficiency with project portfolio management and collaboration platforms. Background on Diagnostics, Medtech, Life Science. Good understanding on Genetics and/or laboratory services. PMP and/or PRINCE2 certification preferred. Ready to Make an Impact? Apply today and join us on an exciting journey where your expertise will shape the future of project management at Vitrolife Group! For any questions about the position, please contact our Vice President Strategy & Sustainability. Vitrolife Group is a global provider of medical devices and genetic services. Based on science and advanced research capabilities, we develop services and products for personalized genetic information and medical device products. We support our customers by improving their clinical practice for the patient's outcome of fertility treatment. We are currently approximately 1 100 colleagues worldwide, with headquarters in Gothenburg, Sweden. Vitrolife Group's products and services are available in more than 110 countries through our own presence in 30 countries and a network of distributors. Vitrolife Group is a sustainable market leader and aims to be the preferred partner for IVF-clinics by providing superior products and services with the vision of fulfilling the dream of having a baby. The Vitrolife share is listed on Nasdaq Stockholm.

SallyQ AB

Hansa Biopharma develops innovative treatments that give patients with rare and serious immune-mediated conditions a chance to a better life. We are now looking for an experienced Senior QA Manager Validation and Quality, to help shape our quality work at one of the most exciting biotech companies in the Nordics. About the role You will be a key player in a QA team of six dedicated colleagues, all based at our office in Lund. As Senior QA Manager, you will drive and approve validation activities - spanning process, cleaning and analytical method validation - with a clear quality perspective. You will act as subject matter expert supporting cross-functional teams, external partner management and regulatory authority inspections. This is the right role for you if you thrive with both strategic ownership and operational presence - where one day you are reviewing validation documentation and the next you are in dialogue with a CDMO or preparing a team for an authority inspection. Your responsibilities: Provide strategic and operational direction for quality management and validation across development, clinical and commercial manufacturing QA review and approval of validation documentation Supplier quality management: guide and qualify external manufacturing partners (CDMOs/CMOs) throughout the product lifecycle Support authority inspections and internal/external audits of suppliers and vendors Cross-functional collaboration with CMC, Regulatory, Clinical and Supply Chain Drive continuous improvement of the Quality Management System (QMS) and proactively identify areas for development Who are you? We believe you are a seasoned QA professional with broad experience across both drug substance (DS) and drug product (DP) manufacturing. You are thorough and results-oriented, but also a natural collaborator who knows when to take the lead and when to seek input from others. We are looking for someone with: Advanced degree (Ph.D. or M.Sc.) in Chemical Engineering, Chemistry, Pharmaceutical Sciences or a related discipline 10+ years of biopharmaceutical industry experience with a focus on QA, process development and validation Proven track record of leading validation activities for DS and DP through clinical and commercial stages Strong knowledge of aseptic manufacturing and biotechnology processes Deep understanding of regulatory requirements (FDA, EMA, ICH) related to manufacturing and validation Experience managing external partners and CDMOs/CMOs Experience of authority inspections (FDA, EMA) as presenter and/or coordinator Strong communication skills and the ability to influence across functions and organisational levels What we offer At Hansa, you will not just have a job - you will have a role where your work directly contributes to changing lives for patients with acute and complex immune disorders. A close-knit, welcoming culture in a mid-sized company where you can see how your contribution makes a difference The opportunity to help build a fully integrated biopharmaceutical company with global reach Talented, driven colleagues with an open and entrepreneurial mindset A strong pipeline built on Hansa’s proprietary IgG-cleaving enzyme technology platform Office in Lund, at the heart of a vibrant Life Science ecosystem Our values At Hansa, we are guided by our core values: Accountability, Courage, Integrity and Pioneering. We believe in the power of diversity and are committed to building an inclusive workplace where every perspective is valued. Appealing? Send in an application as soon as possible. In this recruitment, Hansa Biopharma is collaborating with SallyQ. For questions, please contact Ellinor Crafoord, Senior Recruitment Consultant, +46793554257 or ellinor.crafoord@sallyq.se.

Randstad AB

Arbetsbeskrivning Vill du bidra till att stärka kvalitetssystemen hos en ledande aktör inom läkemedelsbranschen? Vi söker just nu flera drivna och noggranna medarbetare inom kvalitetssäkring (QA) till vår kunds anläggning i Uppsala. Här får du chansen att arbeta med allt från dokumentationshantering till validering av IT-system och strategiskt compliance-arbete, i en roll som säkrar att verksamheten är redo för regulatoriska granskningar (FDA / Audit Readiness). Om rollen och verksamheten I denna dynamiska roll blir du en nyckelperson i kundens kvalitetsteam, där det övergripande fokuset ligger på att upprätthålla högsta möjliga standard inför kommande FDA-inspektioner och externa audits. Beroende på din specifika bakgrund och erfarenhetsprofil kommer tyngdpunkten i ditt uppdrag att ligga inom något eller några av våra fokusområden: dokumentationsadministration, IT-kvalitetssäkring (QA-IT), frisläppning samt strategiskt arbete med sitens centrala kvalitetssystem. Du kommer att arbeta i en modern GMP-miljö där dataintegritet och regelefterlevnad genomsyrar allt arbete. Som konsult hos Randstad blir du en del av ett starkt och sammansvetsat team ute hos vår kund, samtidigt som du har Randstads trygghet och stöd i ryggen. Tjänsten passar dig som trivs i en ansvarsfull roll med stort utrymme för självständigt driv, och som vill utvecklas vidare inom Life Science-sektorn. Vi rekryterar under sommaren, men på grund av ledigheter kan processen och vår återkoppling ta något längre tid än normalt. Vi hanterar ansökningar löpande och uppskattar ditt tålamod under semesterperioden. Varmt välkommen med din ansökan! Ansvarsområden QA Dokumentation & Administration: Ansvara för granskning och arkivering av loggböcker samt administration av dokumentationssystem i eDMS enligt gällande GMP-regler. QA-IT & Dataintegritet: Utföra validering och kvalitetssäkring av datoriserade system samt laboratorieutrustning. Granskning & Godkännande: Utvärdera och godkänna riskbedömningar gällande dataintegritet (Data Integrity Risk Assessments) samt kvalificeringar av IT- och labbsystem. Kvalitetssystem & Compliance (Senior profil): Stärka och utveckla sitens centrala kvalitetssystem med fokus på kontinuerliga förbättringar och höjd compliance-nivå. Ärendehantering: Ansvara för och driva processer kopplade till ändringshantering (Change Control), avvikelser och CAPA-system. Utbildning & Rapportering: Hålla i interna utbildningar inom kvalitetssystem samt sammanställa och presentera compliancerapportering till ledningen. Kvalifikationer Relevant akademisk utbildning inom naturvetenskap, farmaci, ingenjörsvetenskap eller motsvarande område. Erfarenhet av QA-arbete inom läkemedelsindustrin eller annan strikt reglerad GMP-miljö. Gedigen erfarenhet av frisläppning. God förståelse för dokumentationshantering i eDMS samt hantering och arkivering av loggböcker enligt GMP. Erfarenhet av validering och kvalificering av datoriserade system (CSV) samt tillämpning av principer för dataintegritet (Data Integrity). Erfarenhet av att självständigt driva och utreda Change Control, avvikelser och CAPA-ärenden (särskilt meriterande för den seniora profilen). Goda laborativa kunskaper i den utsträckning som krävs för att kunna förstå och kvalitetssäkra de bakomliggande processerna på anläggningen. Språkkrav: Flytande i både svenska och engelska, i såväl tal som skrift. Personliga egenskaper Vi lägger stor vikt vid din personliga lämplighet för denna tjänst. För att trivas och lyckas i rollen är du en metodisk, strukturerad och noggrann person som alltid sätter kvaliteten i första rummet. Du har en mycket god samarbetsförmåga och tar ett naturligt ansvar för att gruppen gemensamt levererar enligt uppsatta tidslinjer och strikta kvalitetskrav. Eftersom miljön kan förändras är du flexibel och kommunikativ, med förmågan att självständigt driva ditt arbete framåt. Vi ser även att du är nyfiken, målmedveten och initiativtagande, och att du med ditt engagemang bidrar till ett positivt och stöttande arbetsklimat i teamet. Om företaget Randstad På Randstad vet vi att alla människor har en plats på arbetsmarknaden. Med verksamhet över hela landet och inom alla kompetensområden hjälper vi människor att hitta ett jobb som känns bra, och där de får möjlighet att växa, utvecklas och uppnå sin fulla potential. Med närmare 600 000 anställda i 38 länder är Randstad världsledande inom HR-tjänster, med målsättningen att bli världens främsta och mest uppskattade partner på arbetsmarknaden. Genom att kombinera vår passion för människor med kraften i dagens teknologi hjälper vi människor och företag att uppnå deras fulla potential. Vi kallar det Human Forward.