Senior Regulatory Affairs Specialist

Our client is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy and submissions for an innovative product portfolio.

This is a highly visible, hands-on role where you will partner closely with R&D, Quality, and Operations to drive regulatory excellence across the full product lifecycle—from development through post-market compliance.

Key Responsibilities

• Lead regulatory strategy for new IVD products and product changes across U.S. and Canada markets, with support for EU/IVDR and global initiatives
• Prepare and submit regulatory filings, including FDA Pre-Subs/Q-Subs, 510(k)s, and Health Canada device licenses
• Serve as the primary regulatory liaison with agencies such as the FDA and Health Canada
• Monitor evolving regulatory requirements and drive implementation across the organization
• Maintain regulatory licenses, device listings, and support EU IVDR transition efforts
• Review complaints and support post-market regulatory compliance activities
• Ensure labeling, documentation, and submissions meet applicable global regulatory standards
• Participate in internal, external, and supplier/vendor audits
• Support Quality Management System (QMS) activities, including CAPA, change control, and document control

Qualifications

• Bachelor’s degree required; Master’s degree preferred in a scientific or technical discipline
• 8–12+ years of regulatory affairs experience within IVD, medical device, biotech, or pharmaceutical environments
• Strong knowledge of FDA regulations, including 21 CFR Part 820
• Demonstrated success leading FDA 510(k) submissions (IVD experience strongly preferred)
• Experience with CE marking (IVDD) and working knowledge of IVDR requirements
• Familiarity with Health Canada medical device licensing
• Experience working within ISO 13485 environments (Lead Auditor certification a plus)
• Strong communication and cross-functional collaboration skills
• Ability to manage multiple priorities in a fast-paced, regulated environment
• Hands-on, team-oriented mindset with the ability to work onsite

Why This Opportunity

• High-impact role with visibility across technical and leadership teams
• Opportunity to shape regulatory strategy for innovative diagnostic technologies
• Collaborative, cross-functional environment supporting product innovation and compliance excellence