Director, Regulatory Affairs

TalentSphere; British Columbia; On-site; CAD 125,000 - 135,000; Full time

Job summary

An IVD company in Greater Vancouver is seeking a Director of Regulatory Affairs to lead regulatory strategy for IVD products. This role involves team management, ensuring compliance with international standards, and directing submissions to FDA and Health Canada. The ideal candidate has over 5 years of regulatory experience and strong leadership skills. Join a dynamic environment focused on global impact in diagnostic healthcare.

Qualifications

• 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.

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.

Skills

Leadership

Cross-functional collaboration

Regulatory compliance

Clinical oversight

Education

MSc in a scientific or engineering field or equivalent experience

Job description

Overview

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.

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.