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Global Regulatory Affairs Specialist, Medical Devices

Job in Minneapolis, Hennepin County, Minnesota, 55400, USA
Listing for: Coloplast
Full Time position
Listed on 2026-08-25
Job specializations:
  • Healthcare
    Healthcare Compliance, Medical Science Liaison
Salary/Wage Range or Industry Benchmark: 107000 - 161000 USD Yearly USD 107000.00 161000.00 YEAR
Job Description & How to Apply Below

Coloplast is seeking a Regulatory Affairs Specialist to manage day-to-day regulatory tasks for medical devices across assigned geographies. You will prepare submissions, monitor status, and support post-market surveillance, change analysis, and vigilance reporting while ensuring design history file documentation stays current.

The role requires 3+ years in regulatory affairs within the medical device industry, familiarity with FDA and EU regulations, and CE marking/Health Canada experience is a

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