Director, Regulatory Affairs

Overview  The Director, RA will lead regulatory strategy and team activities for IVD products across global markets, ensuring successful submissions and ongoing compliance with international standards. This role includes mentoring staff and aligning regulatory efforts with R&D, operations, and commercial functions.
Responsibilities   Lead regulatory strategy and team for IVD products across global markets.
Direct submissions and serve as primary liaison with FDA, Health Canada, and EU Notified Bodies.
Ensure QMS compliance with ISO 13485, MDSAP, and international standards.
Provide clinical oversight support as required.
Provide customer support as required.
Monitor evolving regulations and update policies and processes as needed.
Qualifications   MSc in a scientific or engineering field, or equivalent experience.
5+ years IVD regulatory experience with FDA, Health Canada, and EU IVDR.
Proven expertise in global submissions and compliance programs.
Demonstrated leadership managing teams in a mid-sized company.
Strong cross-functional collaboration skills.
Must have legal authority to work in Canada.
Job Details

Job Title:

Director, Regulatory Affairs

Location:

Greater Vancouver, BC
Industry: In Vitro Diagnostics (IVD) / Med Tech
Type:
Full-Time | On-site

Reports To:

Executive Leadership
Salary Range: $125,000 to $135,000
Why Join  This is an opportunity to lead regulatory affairs in a dynamic IVD company with an innovative pipeline and supportive leadership, while making a global impact on diagnostic healthcare.

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