Regulatory Affairs Lead – NPD for Diagnostics

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.