Senior Manager, Regulatory Affairs
Adaptive Biotechnologies
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 11 days ago
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