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Senior Regulatory & Quality Systems Lead – FDA ; k & QMS

Job in South Brunswick, Middlesex County, New Jersey, USA
Listing for: Essenlix Corporation
Full Time position
Listed on 2026-03-01
Job specializations:
  • Healthcare
  • Quality Assurance - QA/QC
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below
Position: Senior Regulatory & Quality Systems Lead – FDA 510(k) & QMS
A fast-growing medical device company is seeking a Senior Regulatory Affairs & Quality Systems Manager in New Jersey. The successful candidate will lead FDA 510(k) and CLIA submissions, manage the U.S. quality management system, and support cross-border manufacturing compliance. Applicants should have over 5 years of regulatory and quality experience, a related degree, and knowledge of relevant regulations including ISO 13485.

Attractive compensation and benefits package offered, including health insurance and a 401(k).
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Position Requirements
10+ Years work experience
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