Manager, Regulatory Affairs - IVD

Description

• Partner with R&D, Quality, and Operations teams to ensure market readiness
• Act as the primary liaison with regulatory agencies
• Oversee product licensing, labeling, complaints, and post-market surveillance
• Develop and implement strategies to meet global standards ( FDA, EU IVDR, Health Canada, PMDA, NMPA, HAS and TGA , etc.)
• Optimize regulatory workflows and documentation processes
• Monitor regulatory changes to assess impacts on products
• Lead preparation and submission of global regulatory filings (e.g., De Novo, PMA, 510(k))
• Management and mentor a regulatory team
• Mentor junior staff and review work for compliance

Requirements

• Required 5+ years in Regulatory Affairs, with specific experience working in IVDs.
• Authority to work in Canada.
• Proven leadership, project management, and communication skills
• Education: Bachelor’s in Life Sciences, Biotechnology, RAC preferred
• Proven experience with global submissions (e.g. De Novo, PMA, 510(k)), Canada, Europe (IVDR), Japan, China, Singapore, Australia).

Benefits

• Free parking, on-site gym, and a dynamic workplace culture
• Competitive salary
• Health and dental benefits, paid sick days, birthday off

Training + Development

Interview process

Visa Sponsorship

Security clearance