Director, Regulatory Affairs

Job Description

<h3>Job Description</h3><p>Job Description<p><p><strong>Job Title: Director, Regulatory Affairs</strong></p><p><strong>Location:</strong> Greater Vancouver, BC<br /><strong>Industry:</strong> In Vitro Diagnostics (IVD) / MedTech<br /><strong>Type:</strong> Full-Time | On-site<br /><strong>Reports To:</strong> Executive Leadership<br /><strong>Salary Range:</strong> $125,000 to $135,000</p><p>About the Company</p><p>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.</p><p>Position Overview</p><p>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.</p><p>Key Responsibilities</p><ul><li><p>Lead regulatory strategy and team for IVD products across global markets.</p></li><li><p>Direct submissions and serve as primary liaison with FDA, Health Canada, and EU Notified Bodies.</p></li><li><p>Ensure QMS compliance with ISO 13485, MDSAP, and international standards.</p></li><li><p>Provide clinical oversight support as required.</p></li><li><p>Provide customer support as required.</p></li><li><p>Monitor evolving regulations and update policies and processes as needed.</p></li></ul><p>Qualifications</p><ul><li><p>MSc in a scientific or engineering field, or equivalent experience.</p></li><li><p><strong>5+ years IVD regulatory experience</strong> with FDA, Health Canada, and EU IVDR.</p></li><li><p>Proven expertise in global submissions and compliance programs.</p></li><li><p>Demonstrated leadership managing teams in a mid-sized company.</p></li><li><p>Strong cross-functional collaboration skills.</p></li><li><p><strong>Must have legal authority to work in Canada.</strong></p></li></ul><p>Why Join</p><p>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.</p><p>#TSSHP LI-TS1 </p><p>#LI-TS1 </p><p>Job Posting ID: #16712441</p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p></p></p>