Regulatory Affairs Principal
Cepheid(1 month ago)
About this role
The Regulatory Affairs Principal at Cepheid (a Danaher company) leads regulatory activities for new product development teams supporting medium to complex assay, instrument, and software projects. The role drives regulatory strategy and compliance for product submissions and approvals, and supports continuous improvement within the Regulatory Affairs New Product Development organization based in Sunnyvale, CA with potential remote consideration.
Required Skills
- Regulatory Submissions
- Regulatory Strategy
- IVDR
- WHO PQ
- 510(k)
- De Novo
- PMA
- Clinical Review
- Design Controls
- Project Management
+2 more
Qualifications
- Bachelor's Degree in Applicable Field
- Master's Degree in Applicable Field
- Doctoral Degree in Applicable Field
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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