Biotech jobs in United States

Title:Manager, Regulatory Affairs (IVD)
Location: Greater Vancouver On-Site
Position: Permanent, Full-Time
Workplace Type: On-site
Reports To: Director
Salary Range: $100,000 to $110,000 per annum

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:

1. 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
   • Manage and mentor a regulatory team
2. Compliance & Strategy:
   • Develop and implement strategies to meet global standards (FDA, EU IVDR, Health Canada, PMDA, NMPA, HAS and TGA, etc.)
   • Monitor regulatory changes to assess impacts on products
   • Oversee product licensing, labeling, complaints, and post-market surveillance
3. Collaboration & Mentorship:
   • Partner with R&D, Quality, and Operations teams to ensure market readiness
   • Mentor junior staff and review work for compliance
4. Process Improvement:
   • Optimize regulatory workflows and documentation processes

Qualifications:

• Education: Bachelor’s in Life Sciences, Biotechnology, RAC preferred
• Experience:
  • Required 6+ 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.

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.

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Job Posting ID:#16567019