Senior Regulatory Affairs Lead - Medical Devices (Hybrid)
System One
System One in Sunnyvale, CA seeks a Sr. Regulatory Affairs Specialist for a contract engagement. The candidate will craft regulatory plans, review design inputs/outputs, and submit FDA 510(k) and Health Canada filings. Strong cross-functional collaboration is required to guide product teams and shape global regulatory strategies. Requirements include a BS in a related field and at least 8 years of regulatory affairs experience in medical devices, with expertise in US, Canada, and EU MDR #J-18808-Ljbffr System One
Vacancy posted 1 day ago
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