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Check out JobsAI Regulatory Affairs Manager (Temporary, Full-Time)
Company Name
Adaptive Biotechnologies Corp.
Job Overview
The Regulatory Affairs Manager is responsible for US FDA and EU regulatory submission activities, supporting the development and commercialization of in vitro diagnostic (IVD)/LDT and companion diagnostic (CDx) products. This includes leading the preparation of FDA pre-submissions, IDE, 510(k), PMA, and EU Technical Documentation under IVDR.
Collaboration
The manager will collaborate with:
- R&D
- Quality
- Medical Affairs
- Business Development
Position Details
This is a temporary, full-time, 6-month position.