Senior Regulatory & Quality Lead, FDA ; k & ISO
Job in
South Brunswick, Middlesex County, New Jersey, USA
Listed on 2026-02-11
Listing for:
Essenlix
Full Time
position Listed on 2026-02-11
Job specializations:
-
Healthcare
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
A fast-growing medical device company in New Jersey seeks a Senior Regulatory Affairs & Quality Systems Manager. This role requires leading FDA 510(k) submissions, ensuring compliance with quality standards, and managing cross-functional teams. Candidates should have a relevant Bachelor's degree and at least 5 years of experience in regulatory affairs and quality systems, including knowledge of FDA regulations and ISO certifications.
Competitive salary and benefits offered.
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Position Requirements
10+ Years
work experience
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