Manager, Regulatory Affairs - IVD
TalentSphere Staffing Solutions
Date: 10 hours ago
City: Richmond, BC
Contract type: Full time

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
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
Canada
Toronto: 416.900.3435 Calgary: 403.910.9222 Edmonton: 587.333.7929 Halifax: 902.800.7808 Kelowna: 250.448.8880 Montreal: 438.448.4300 Mississauga: 905.919.3688 Ottawa: 613.783.1441 Vancouver: 778.807.9777 Victoria: 250.294.8095 Winnipeg: 204.285.3905
United States
USA Toll-Free: 1855.900.3435 Dallas 469.498.2002 Los Angeles 213.290.4030
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
- 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.
- Competitive salary
- Health and dental benefits, paid sick days, birthday off
- Free parking, on-site gym, and a dynamic workplace culture
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
Canada
Toronto: 416.900.3435 Calgary: 403.910.9222 Edmonton: 587.333.7929 Halifax: 902.800.7808 Kelowna: 250.448.8880 Montreal: 438.448.4300 Mississauga: 905.919.3688 Ottawa: 613.783.1441 Vancouver: 778.807.9777 Victoria: 250.294.8095 Winnipeg: 204.285.3905
United States
USA Toll-Free: 1855.900.3435 Dallas 469.498.2002 Los Angeles 213.290.4030
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resume