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Regulatory Manager, MedTech—US; -Saving Devices
Job in
Golden, Jefferson County, Colorado, 80401, USA
Listed on 2026-07-25
Listing for:
XVIVO
Full Time
position Listed on 2026-07-25
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
XVIVO, based in Golden, CO, is seeking a Regulatory Manager to lead US regulatory activities and ensure lifecycle compliance from development through commercialization. Reporting to the Quality & Regulatory Director, you will liaise with authorities and collaborate across teams to drive compliance.
You will prepare and submit filings (IDE, PMA, 510(k)), guide labeling, post‑approval changes, and ensure overall regulatory readiness. Salary range $110,000-$140,000 with comprehensive benefits.
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