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Global Regulatory Affairs Lead, Medical Devices

Job in Mason, Warren County, Ohio, 45040, USA
Listing for: AtriCure
Full Time position
Listed on 2026-08-06
Job specializations:
  • Healthcare
    Healthcare Compliance, Medical Science Liaison
Salary/Wage Range or Industry Benchmark: 106000 - 130000 USD Yearly USD 106000.00 130000.00 YEAR
Job Description & How to Apply Below

Atri Cure, Inc. in Minnesota is seeking a Senior Regulatory Affairs Specialist to manage regulatory submissions for US and international markets.

You will prepare 510(k) submissions, PMA supplements, and global change documents, serving as regulatory lead on product development projects and post-market modifications to sustain approvals. This role requires collaboration with cross-functional teams, strong technical writing, and frequent interaction with FDA, EU Notified Bodies, Health Canada, and

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