Regulatory Affairs Lead – NPD for Diagnostics
radiometerSunnyvale, CA
Regulatory Affairs Lead – NPD for Diagnostics
radiometerSunnyvale, CA
yesterday
Industries
Electromedical and Electrotherapeutic Apparatus ManufacturingIn-Vitro Diagnostic Substance ManufacturingResearch and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)About the role
Cepheid, located in Sunnyvale, CA, seeks a Regulatory Affairs Principal to lead regulatory strategy for new product development. You will prepare submissions (US FDA, IVDR, WHO/PQ) and coordinate with cross‑functional teams to secure timely approvals for software and hardware solutions.
The role emphasizes cybersecurity, DBS tool experience, and providing clear regulatory plans for US and EU markets, with opportunities for growth within Danaher’s global ecosystem.
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JOB OVERVIEW
Experience level
Manager
Location
Sunnyvale, CA
Occupation
Regulatory Affairs Managers
Industry
Electromedical and Electrotherapeutic Apparatus Manufacturing
Posted
yesterday
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