Manager Regulatory Affairs - IVD
Manager Regulatory Affairs - IVD
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Job Description
Title:Manager Regulatory Affairs (IVD)
Location: Greater Vancouver OnSite
Position: Permanent FullTime
Workplace Type: Onsite
Reports To: Director
Salary Range: $100000 to $110000 per annum
Advance global health by leading regulatory efforts for cuttingedge diagnostics
Position Overview:
Join a growing IVD company as Manager Regulatory Affairs (IVD). With your 6 years of IVD experience and RAC certificationyou 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 postmarket surveillance labeling and change notifications. You will manage regulatory staff and collaborate crossfunctionally 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 postmarket 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: Bachelors in Life Sciences Biotechnology RAC preferred
- Experience:
- Required 6 years in Regulatory Affairs with specific experience working inIVDs.
- 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 onsite gym and a dynamic workplace culture
Whats 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.
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Job Posting ID:#
Thank you for your interest in this job posting.
We look forward to hearing from you.
TalentSphere Staffing Solutions
talentsphere
Canada
United States
Required Experience:
Manager
Employment Type
Full-Time
