Manager, Regulatory Affairs
3 days ago
Overview Manager, Regulatory Affairs (IVD) role at TalentSphere Staffing Solutions. Location: Greater Vancouver – On-Site. Employment type: Permanent, Full-Time. Salary Range: $90,000 to $100,000 per annum. With 6+ years of IVD experience and RAC certification, you will lead regulatory strategies and submissions to support global market approvals for diagnostic medical devices. Responsibilities include preparing submissions (510(k), CE, Health Canada, WHO, etc.), overseeing product licensing, complaint handling, post-market surveillance, labeling, and change notifications. You will manage regulatory staff and collaborate cross-functionally with leadership, product development, and quality teams. Key Responsibilities Regulatory Leadership: Lead preparation and submission of global regulatory filings (e.g., De Novo, PMA, 510(k)) Act as the primary liaison with regulatory agencies Management and mentor a regulatory team Compliance & Strategy: Develop and implement strategies to meet global standards ( FDA, EU IVDR, Health Canada, PMDA, NMPA, HAS and TGA , etc.) Proven leadership, project management, and communication skills Monitor regulatory changes to assess impacts on products Oversee product licensing, labeling, complaints, and post-market surveillance Collaboration & Mentorship: Partner with R&D, Quality, and Operations teams to ensure market readiness Mentor junior staff and review work for compliance Process Improvement: Optimize regulatory workflows and documentation processes Qualifications Education: Bachelor’s in Life Sciences, Biotechnology, RAC preferred Experience: Required 5+ years in Regulatory Affairs, with specific experience working in IVDs. Proven experience with global submissions (e.g. De Novo, PMA, 510(k)), Canada, Europe (IVDR), Japan, China, Singapore, Australia). Proven leadership, project management, and communication skills Authority to work in Canada. Perks Competitive salary Health and dental benefits, paid sick days, birthday off Free parking, on-site gym, and a dynamic workplace culture What’s Offered This is an exciting opportunity to join a dynamic organization driving impactful diagnostic solutions. How to Apply For a full job description contact Carla Campbell, Executive Talent Consultant, TalentSphere – Life Sciences, at To apply, please use the TalentSphere job board. #J-18808-Ljbffr
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Regulatory Affairs
4 weeks ago
Vancouver, Canada AbCellera Biologics Full timeJob ID: 23320 From target to the clinic. AbCellera’s platform integrates biology, computation, and engineering to develop impactful antibody-based medicines. We’re scientists, engineers, and business professionals who work together to turn scientific insights into breakthrough medicines. We pursue truth and scientific rigor. We think independently, act...
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Regulatory Affairs
2 weeks ago
Vancouver, Canada AbCellera Biologics Full timeJob ID: 23320 From target to the clinic. AbCellera’s platform integrates biology, computation, and engineering to develop impactful antibody-based medicines. We’re scientists, engineers, and business professionals who work together to turn scientific insights into breakthrough medicines. We pursue truth and scientific rigor. We think independently, act...
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Regulatory Affairs
3 weeks ago
Vancouver, Canada AbCellera Biologics Full timeJob ID: 23320 From target to the clinic. AbCellera’s platform integrates biology, computation, and engineering to develop impactful antibody-based medicines. We’re scientists, engineers, and business professionals who work together to turn scientific insights into breakthrough medicines. We pursue truth and scientific rigor. We think independently, act...
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Regulatory Affairs
2 weeks ago
Vancouver, Canada AbCellera Biologics Full timeJob ID: 23320 From target to the clinic. AbCellera’s platform integrates biology, computation, and engineering to develop impactful antibody-based medicines. We’re scientists, engineers, and business professionals who work together to turn scientific insights into breakthrough medicines. We pursue truth and scientific rigor. We think independently, act...
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Manager, Regulatory Affairs
2 weeks ago
Vancouver, Canada STEMCELL Technologies Full time**Job Description Summary**: Use your expert knowledge of regulatory compliance, including cGMP and ISO 13485/9001 to drive innovation as a Manager with the Regulatory Affairs team. Your expertise will support regulatory submissions for products that do not fall into standard regulations such as a medical device or drug. Your people skills will allow you to...
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Manager, Regulatory Affairs
2 weeks ago
Vancouver, Canada STEMCELL Technologies Full time**Job Description Summary**: Are you ready to take on a pivotal role as a Regulatory Affairs Manager? Join STEMCELL Technologies, a world-leading company in the life sciences industry, and work alongside renowned diagnostic partners. As our Regulatory Affairs Manager, you will have the opportunity to exchange ideas and have a seat at the table,...
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VP, Regulatory Affairs
4 weeks ago
Vancouver, Canada AbCellera Full timeJoin to apply for the VP, Regulatory Affairs role at AbCellera From target to the clinic. AbCellera’s platform integrates biology, computation, and engineering to develop impactful antibody-based medicines. We’re scientists, engineers, and business professionals who work together to turn scientific insights into breakthrough medicines. We pursue truth...
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VP, Regulatory Affairs
4 weeks ago
Vancouver, Canada AbCellera Full timeJoin to apply for the VP, Regulatory Affairs role at AbCellera From target to the clinic. AbCellera’s platform integrates biology, computation, and engineering to develop impactful antibody-based medicines. We’re scientists, engineers, and business professionals who work together to turn scientific insights into breakthrough medicines. We pursue truth...
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Regulatory Affairs Lead
4 weeks ago
Vancouver, Canada University of British Columbia - Staff Full timeStaff - Non Union Job Category M&P - AAPS Job Profile AAPS Salaried - Research and Facilitation, Level C Job Title Regulatory Affairs Lead Department Regier Laboratory | School of Population and Public Health | Faculty of Medicine Compensation RangeThe Compensation Range is the span between the minimum and maximum base salary for a position. The midpoint of...
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Regulatory Affairs Lead
4 weeks ago
Vancouver, Canada University of British Columbia - Staff Full timeStaff - Non Union Job Category M&P - AAPS Job Profile AAPS Salaried - Research and Facilitation, Level C Job Title Regulatory Affairs Lead Department Regier Laboratory | School of Population and Public Health | Faculty of Medicine Compensation Range The Compensation Range is the span between the minimum and maximum base salary for a position. The midpoint of...
