Senior Manager, Regulatory Affairs

Adaptive Biotechnologies · Remote

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Role summary

Senior Manager leading ex-US regulatory strategy for NGS-based in vitro diagnostic products, with focus on EU IVDR and Health Canada approvals. Role expands international market presence, manages biopharma partnerships for companion diagnostics, and coordinates with regulatory authorities and Notified Bodies.

What they're looking for

Extensive ex-US regulatory affairs experience, particularly EU IVDR and Health Canada medical device frameworks
Demonstrated expertise in in vitro diagnostic (IVD) or companion diagnostic (CDx) regulatory pathways
Proven experience leading regulatory strategy development and international market expansion
Track record of managing Notified Body relationships and technical documentation
Strong cross-functional leadership skills with ability to mentor and develop team members
Experience interfacing with regulatory authorities and biopharma partners on complex submissions

What you'll be doing

Develop and execute ex-US regulatory strategy prioritizing EU IVDR and Health Canada approvals
Build regulatory roadmap for future international markets including UKCA, TGA, NMPA, and other regions
Lead negotiations and serve as primary contact with international regulatory authorities and Notified Bodies
Manage biopharma partner relationships and align companion diagnostic regulatory strategy with drug development timelines
Maintain international technical files, design dossiers, and post-market surveillance obligations

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