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Senior Regulatory Affairs Lead – Medical Devices (Hybrid

Job in Mountain View, Santa Clara County, California, 94039, USA
Listing for: System One
Full Time position
Listed on 2026-07-30
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist, Healthcare Compliance, Medical Science Liaison
Salary/Wage Range or Industry Benchmark: 114000 - 124800 USD Yearly USD 114000.00 124800.00 YEAR
Job Description & How to Apply Below
Position: Senior Regulatory Affairs Lead – Medical Devices (Hybrid)

System One is seeking a Regulatory Affairs Specialist IV in Sunnyvale, CA, to lead regulatory strategy and submissions for medical devices across the U.S., Canada, and global markets. This 6‑month contract role requires deep regulatory expertise and strong cross‑functional leadership.

The ideal candidate will drive regulatory plans, author pivotal documents such as 510(k) submissions, and coordinate with international teams to support global approvals. Hybrid work with onsite days is offered.

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Position Requirements
10+ Years work experience
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