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Impactful Regulatory Affairs Associate — Medical Devices

Job in Boulder, Boulder County, Colorado, 80301, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2026-01-29
Job specializations:
  • Healthcare
    Medical Science Liaison, Healthcare Compliance
Job Description & How to Apply Below
A medical device regulatory firm is seeking an Associate Regulatory Affairs Manager to support the development, review, and submission of regulatory documents for medical devices and IVD products. The position requires collaboration with cross-functional teams to ensure compliance with FDA and ISO regulations. Candidates should hold a bachelor's degree and possess 4-6 years of regulatory experience, particularly with 510(k) submissions.

Strong organizational skills and the ability to manage multiple projects are essential.
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Position Requirements
10+ Years work experience
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