Staff Regulatory Affairs - Bangalore
Cepheid(1 month ago)
About this role
The Staff Regulatory Affairs position at Beckman Coulter Life Sciences supports global regulatory activities for in vitro diagnostic reagents and systems, including registrations, labeling, and post-market compliance. The role partners with cross-functional teams during new product development and product lifecycle management to ensure compliance with domestic and international regulatory standards. It is based in the Miami Regulatory Affairs team within Danaher Life Sciences.
Required Skills
- Regulatory Strategy
- Global Registration
- Documentation Management
- Submission Management
- Audit Support
- Labeling
- Product Lifecycle
- Cross-Functional Collaboration
- Risk Management
- Quality Systems
+1 more
Qualifications
- BS in Life Sciences or Engineering
- 8-10 Years Experience (Medical Device/Diagnostics)
- CQM
- CQE
- CQA
- RAC
- CLIA
- Six Sigma
- Lean
About Cepheid
cepheid.comCepheid is delivering a better way to improve patient outcomes by enabling access to molecular diagnostic testing everywhere.
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