Regulatory Affairs Specialist

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 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.

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.

Technogarden AB

Sever Pharma Solutions är en kontraktsutvecklare och tillverkare specialiserad på högpotenta läkemedel. Huvudkontoret i Malmö har utvecklat och tillverkat läkemedel sedan närmare 50 år enligt de höga krav som ställs på läkemedelsföretag. Våra kunder är allt från stora globala till mindre läkemedelsföretag och vi har drygt 320 anställda i Malmö och USA. Vill du vara en viktig nyckelperson i en växande, internationell organisation där kontinuerlig förbättring och patientsäkerhet är ledord? Vi söker nu en erfaren och engagerad, senior QP Specialist som kan vara del i Sever Pharma Solutions fortsätta tillväxt och därmed är beredd att bidra med din kunskap till fortsatt utveckling och stärkt kvalitetskultur i en organisation i förändring.  Kvalitetsavdelningen som du kommer att tillhöra, består av ett 50-tal personer och du kommer att rapportera direkt till VP Director Quality. Du kommer också att ha nära samarbete med ytterligare en erfaren QP.  Om rollen Som QP har du en central och självständig roll med ansvar för att säkerställa att tillverkade läkemedelsprodukter uppfyller gällande GMP-krav, regulatoriska krav och interna kvalitetsstandarder innan certifiering och frisläppning. Rollen innebär nära samarbete med QA, QC, produktion och andra tvärfunktionella grupper i verksamheten. Dina ansvarsområden Certifiera och frisläppa tillverkade läkemedelsbatcher i enlighet med gällande GMP och regulatoriska krav  Säkerställa att råvaror, förpackningsmaterial och färdiga produkter har testats och godkänts enligt fastställda specifikationer  Granska och godkänna avvikelser, förändringar, CAPA och kvalitetsrelaterade utredningar  Säkerställa efterlevnad av europeiska och internationella regulatoriska krav, inklusive krav från Läkemedelsverket, EMA och FDA  Bidra till utveckling och förbättring av kvalitetsprocesser och kvalitetskultur  Din bakgrund och erfarenhet Du har en akademisk examen inom farmaci, kemi, biomedicin eller liknande på Master nivå Du har flera års erfarenhet som Quality Assurance specialist men gärna även inom andra kvalitetsrelaterade uppgifter i en GMP styrd verksamhet Du är certifierad QP av läkemedelsverket och har flerårig erfarenhet inom internationell läkemedelsindustri och uppfyller Läkemedelsverkets standard HSLF-FS 2021:102 Du har ett agilt arbetssätt och kan prioritera dina arbetsuppgifter och du är en god och tydlig kommunikatör Tidigare erfarenhet av steril tillverkning inom läkemedelsindustrin är meriterande Du talar och skriver svenska och engelska flytande Som person är du trygg, van att arbeta självständigt och har förmåga att fatta egna beslut grundade på din kunskap och dina erfarenheter. Du driver dina projekt effektivt och med ständig förbättring som mål. Du har mycket god samarbetsförmåga samt integritet i din roll. Du trivs i en utvecklande miljö där förändrings- och förbättringsarbete är en del av vardagen. Du är noggrann, strukturerad och har ett utpräglat kvalitetsmedvetande som genomsyrar dina handlingar. Du kommer att vara en viktig del i ett mycket trevligt gäng i en stimulerande miljö där du får ta del av nya utvecklingsprojekt som ofta blir verklighet i form av state-of-the art läkemedel.  Vi ser fram emot att få berätta mer om tjänsten och Sever Pharma Solutions! Tveka inte att höra av dig för mer information eller för att få svar på dina frågor. Vi kommer att granska ansökningarna löpande. Varmt välkommen!