Senior Regulatory Affairs Lead - Medical Devices (Hybrid)
System One
System One is seeking a Sr. Regulatory Affairs Specialist in Sunnyvale, CA. The role requires a BS degree and at least 8 years of Regulatory Affairs experience in medical devices. You will lead regulatory plans, prepare FDA 510(k) submissions, and guide product teams on US, Canada, and EU pathways. You will collaborate with international teams to support global submissions and drive cross-functional alignment, ensuring timely approvals and compliant labeling and risk management. #J-18808-Ljbffr System One
Vacancy posted 15 hours ago
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