Manager, Regulatory Affairs - IVD

TalentSphere Staffing Solutions; Richmond; On-site; CAD 100,000 - 110,000; Full time

Job summary

An established industry player in the diagnostics field is seeking a Manager of Regulatory Affairs to lead regulatory strategies and submissions for innovative diagnostic medical devices. This role requires a seasoned professional with over 6 years of experience in IVDs and a passion for advancing global health. You will spearhead regulatory efforts, ensuring compliance with international standards while mentoring a dynamic team. This exciting opportunity offers a collaborative environment where your contributions will directly impact the development of cutting-edge solutions. If you're ready to make a significant difference in the health sector, this position is for you.

Benefits

Competitive salary

Health and dental benefits

Paid sick days

Birthday off

Free parking

On-site gym

Dynamic workplace culture

Qualifications

• 6+ years of experience in Regulatory Affairs, specifically in IVDs.
• Proven experience with global submissions and regulatory compliance.

Responsibilities

• Lead preparation and submission of global regulatory filings.
• Develop strategies to meet global regulatory standards.

Skills

Regulatory Affairs

Project Management

Communication Skills

Leadership

Education

Bachelor’s in Life Sciences

RAC Certification

Job description

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:

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 [e-mail]. To apply, please use the TalentSphere job board.

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Job Posting ID:#16567019