OverviewThe 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.ResponsibilitiesLead 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.QualificationsMSc 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.Solid cross-functional collaboration skills.Must have legal authority to work in Canada.Job DetailsJob Title: Director, Regulatory AffairsLocation: Greater Vancouver, BCIndustry: In Vitro Diagnostics (IVD) / MedTechType: Full-Time | On-siteReports To: Executive LeadershipSalary Range: $125,000 to $135,000Why JoinThis 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.#J-18808-Ljbffr

📌 Director, Regulatory Affairs - C$125,000 - C$135,000 A Year (Toronto)
🏢 TalentSphere Staffing Solutions
📍 Toronto