Manager, Regulatory Affairs - IVD at TalentSphere

Job Description:

Latest job information from TalentSphere for the position of Manager, Regulatory Affairs - IVD. If the Manager, Regulatory Affairs - IVD vacancy in Richmond matches your qualifications, please submit your latest application or CV directly through the updated Jobkos job portal.

Please note that applying for a job may not always be easy, as new candidates must meet certain qualifications and requirements set by the company. We hope the career opportunity at TalentSphere for the position of Manager, Regulatory Affairs - IVD below matches your qualifications.

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: $90,000 to $100,000 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:

• 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 5+ 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 . To apply, please use the TalentSphere job board.#TSSHP LI-TS1
#LI-TS1
Job Posting ID: #16648708

Job Info:

• Company: TalentSphere
• Position: Manager, Regulatory Affairs - IVD
• Work Location: Richmond
• Country: CA

How to Submit an Application:

After reading and understanding the criteria and minimum qualification requirements explained in the job information Manager, Regulatory Affairs - IVD at the office Richmond above, immediately complete the job application files such as a job application letter, CV, photocopy of diploma, transcript, and other supplements as explained above. Submit via the Next Page link below.