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Regulatory Affairs Leader – FDA PMA​/k Strategy

Job in New Brunswick, Middlesex County, New Jersey, 08933, USA
Listing for: X4 Life Sciences
Full Time position
Listed on 2026-02-28
Job specializations:
  • Healthcare
    Healthcare Management
  • Management
    Healthcare Management
Salary/Wage Range or Industry Benchmark: 100000 - 125000 USD Yearly USD 100000.00 125000.00 YEAR
Job Description & How to Apply Below
Position: Regulatory Affairs Leader – FDA PMA/510(k) Strategy
A fast-growing medical device manufacturer in New Jersey is seeking an exceptional FDA/PMA Regulatory Affairs Expert. This role entails owning FDA strategy and PMA and 510(k) submissions. The successful candidate will provide strategic regulatory guidance and ensure compliance with FDA regulations. Ideal applicants will have over 10 years of experience in the industry, proven success with PMA approvals, and strong communication skills.

This is a unique opportunity for leadership in a pivotal phase of growth.
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