Director, Regulatory Affairs

Description

• Direct submissions and serve as primary liaison with FDA, Health Canada, and EU Notified Bodies.
• Provide clinical oversight support as required.
• Provide customer support as required.
• Lead regulatory strategy and team for IVD products across global markets.
• Monitor evolving regulations and update policies and processes as needed.
• Ensure QMS compliance with ISO 13485, MDSAP, and international standards.

Requirements

• MSc in a scientific or engineering field, or equivalent experience.
• Proven expertise in global submissions and compliance programs.
• Must have legal authority to work in Canada.
• 5+ years IVD regulatory experience with FDA, Health Canada, and EU IVDR.
• Strong cross-functional collaboration skills.
• Demonstrated leadership managing teams in a mid-sized company.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance