Manager, Regulatory Affairs - IVD

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

Advance 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 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 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 [email protected]. To apply, please use the TalentSphere job board.

TSSHP LI-TS1

LI-TS1

Job Posting ID: #16648708

Thank you for your interest in this job posting.

We look forward to hearing from you.

TalentSphere Staffing Solutions

talentsphere.ca

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