Job Description
Job Description
Job Description
Job Title: Director, Regulatory Affairs
Location: Greater Vancouver, BC
Industry: In Vitro Diagnostics (IVD) / MedTech
Type: Full-Time | On-site
Reports To: Executive Leadership
Salary Range: $125,000 to $135,000
About the Company
Our client is a growing IVD company recognized for advancing diagnostic accuracy and regulatory excellence. Headquartered in Greater Vancouver, the company is expanding globally with a strong focus on quality and compliance.
Position 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.
Key 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.
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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Job Posting ID: #16712441