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Regulatory Affairs Specialist - ISO Focus

Job in City of Rochester, Rochester, Monroe County, New York, 14602, USA
Listing for: Keller Executive Search
Full Time position
Listed on 2026-03-01
Job specializations:
  • Healthcare
    Healthcare Compliance, Healthcare Management, Healthcare Administration
Salary/Wage Range or Industry Benchmark: 75000 - 95000 USD Yearly USD 75000.00 95000.00 YEAR
Job Description & How to Apply Below
Position: Regulatory Affairs Specialist - ISO 13485 Focus
Location: City of Rochester

A medical device manufacturer in New York State is seeking a Regulatory Affairs Specialist to maintain ISO 13485 compliance and support regulatory documentation. The ideal candidate will have 3 to 7 years of experience in medical device quality and regulatory affairs. The role involves managing audit programs, regulatory compliance, and collaborating across teams in a growth-stage environment. A comprehensive benefits package, including a salary range of $75,000 to $95,000, is offered.
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