Director, Regulatory Affairs

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

Job summary

A leading IVD company in Greater Vancouver is seeking a Director, Regulatory Affairs to lead global regulatory strategy and ensure compliance. You will manage submissions to the FDA, Health Canada, and EU regulatory bodies, while leading a team dedicated to achieving excellence in diagnostic accuracy. The ideal candidate will have 5+ years of relevant experience and a Master's degree in a scientific or engineering field.

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 for IVD products across global markets.
• Direct submissions and serve as liaison with FDA and Health Canada.
• Ensure QMS compliance with ISO 13485 and MDSAP.

Skills

Regulatory strategy leadership

Cross-functional collaboration

Clinical oversight

Quality management systems compliance

Education

MSc in a scientific or engineering field

Job description

Overview

Director, Regulatory Affairs role in the In Vitro Diagnostics (IVD) / MedTech industry. Location: Greater Vancouver, BC. Type: Full-Time | On-site. Reports To: Executive Leadership. Salary Range: $125,000 to $135,000.

• 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.