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Senior Regulatory Affairs Lead, Medical Devices (Hybrid

Job in Waltham, Middlesex County, Massachusetts, 02254, USA
Listing for: CH01 CHE Fresenius Medical Care (Schweiz) AG
Full Time position
Listed on 2026-08-22
Job specializations:
  • Healthcare
    Healthcare Compliance, Medical Science Liaison
Salary/Wage Range or Industry Benchmark: 109000 - 183000 USD Yearly USD 109000.00 183000.00 YEAR
Job Description & How to Apply Below
Position: Senior Regulatory Affairs Lead, Medical Devices (Hybrid)

CH01 CHE Fresenius Medical Care (Schweiz) AG is seeking a Principal RA Associate Devices to develop regulatory strategies for medical devices. This role involves preparing submissions for FDA and working closely with product development teams to ensure compliance with regulations.

The ideal candidate will have a Bachelor's Degree, minimum of 8 years of experience in regulatory submissions, and a strong understanding of U.S. and international regulations. This position offers a hybrid work model and competitive salary.

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Position Requirements
10+ Years work experience
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