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Hands-on Regulatory & Quality Specialist — Medical Devices
Job in
City of Rochester, Rochester, Monroe County, New York, 14602, USA
Listed on 2026-03-01
Listing for:
Keller Executive Search
Full Time
position Listed on 2026-03-01
Job specializations:
-
Healthcare
Medical Science -
Quality Assurance - QA/QC
Job Description & How to Apply Below
A growth-stage medical device manufacturer in New York seeks a Regulatory Affairs Specialist to maintain and support their ISO 13485-compliant Quality Management System. The role involves managing audit processes, updating regulatory documentation, and collaborating with cross-functional teams to meet compliance requirements. Candidates should hold a Bachelor's degree and have 3 to 7 years of hands-on experience in a medical device regulatory environment.
A comprehensive benefits package is included, with a salary range of $75,000 – $95,000 based on experience.
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