Manager, Regulatory Affairs - IVD

Overview

Lead global IVD regulatory strategy, submissions, and team management.

Key Responsibilities

• regulatory filings
• workflow optimization
• agency liaison
• regulatory monitoring
• post‑market surveillance
• team management

Tasks

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

Requirements

• regulatory affairs
• ivds
• global submissions
• bachelor's
• leadership
• 5+ years

What You Bring

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

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Benefits

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

About Talentsphere Staffing Solutions

-Combining nimble, tech-enabled sourcing with niche industry know-how, they fill roles ranging from temporary and contract to executive leadership. -Their consultants work sectors such as IT, data analytics, life sciences, construction, finance, marketing, HR and engineering. -They’ve helped clients execute major projects—from tech system rollouts to executive hires—by delivering tailored talent fast. -With a consultancy mindset, they’ve positioned themselves for hands-on partnerships, acting as strategic talent advisors rather than just recruiters. -They stand out by offering both speed on temporary and interim needs, and thorough executive search when senior leadership is at stake. -Operating across major Canadian cities and the U.S., they bring local market insight to every placement.

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