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Manager, Regulatory Affairs

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Metro Vancouver, Canada TalentSphere Full time

 Title: Manager, Regulatory Affairs (IVD)Location: Greater Vancouver On-SitePosition: Permanent, Full-Time Workplace Type: On-siteReports To: DirectorSalary Range:  $90,000 to $100,000 per annumAdvance global health by leading regulatory efforts for cutting-edge diagnostics Position Overview:Join a growing IVD company as Manager, Regulatory Affairs (IVD).  With your 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 agenciesManagement and mentor a regulatory teamCompliance & 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 skillsMonitor regulatory changes to assess impacts on productsOversee product licensing, labeling, complaints, and post-market surveillanceCollaboration & Mentorship: Partner with R&D, Quality, and Operations teams to ensure market readinessMentor junior staff and review work for complianceProcess Improvement: Optimize regulatory workflows and documentation processesQualifications:Education: Bachelor’s in Life Sciences, Biotechnology, RAC preferredExperience: 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 skillsAuthority to work in Canada.Perks:Competitive salary Health and dental benefits, paid sick days, birthday offFree parking, on-site gym, and a dynamic workplace cultureWhat’s Offered:This is an exciting opportunity to join a dynamic organization driving impactful diagnostic solutions.To Apply:For a full job description contact Carla Campbell, Executive Talent Consultant, TalentSphere – Life Sciences, at ccampbell@talentsphere.ca.  To apply, please use the TalentSphere job board.#TSSHP LI-TS1#LI-TS1Job Posting ID: #16648708