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Manager, Regulatory Affairs

1 month ago

Richmond, Canada TalentSphere Staffing Solutions Full time
Job Description: Manager, Regulatory Affairs (IVD) – CONFIDENTIAL SEARCH

Location: Greater Vancouver On-Site
Reporting to: Director
Salary Range: $90,000 to $120,000 per annum

Position Overview:
A growing organization in the medical diagnostics sector is seeking a Manager, Regulatory Affairs (IVD) to lead regulatory projects, ensure compliance with global requirements, and support product registrations across multiple jurisdictions. This role involves managing cross-functional teams, mentoring junior staff, and developing regulatory strategies to achieve market access for innovative IVD products.

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.
  • 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.
  • 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, or related field (advanced degree preferred).
  • Experience:
    • 8+ years in Regulatory Affairs, focusing on IVDs or medical devices.
    • Proven experience with global submissions (e.g.,
      • De Novo, PMA, 510(k)), Canada, Europe (IVDR), Japan, China, Singapore, Australia).
  • Skills:
    • Strong understanding of global regulatory standards.
    • Exceptional organizational, problem-solving, and communication skills.
    • Authority to work in Canada.

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.

TSSHP LI-TS1
Job Posting ID: #16567019