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Senior Regulatory Affairs Specialist: SaMD & Med Devices

Job in Mobile, Mobile County, Alabama, 36624, USA
Listing for: OrganOx
Full Time position
Listed on 2026-09-30
Job specializations:
  • Healthcare
  • Quality Assurance - QA/QC
Salary/Wage Range or Industry Benchmark: 100000 - 140000 USD Yearly USD 100000.00 140000.00 YEAR
Job Description & How to Apply Below

Organ Ox, a global medical device company, seeks a Senior Regulatory Affairs Specialist to prepare regulatory submissions for North America including FDA and Health Canada and to support ISO, GMP compliance. You will collaborate with cross-functional teams, manage submissions for SaMD/SiMD and electromechanical devices, and maintain regulatory intelligence, with up to 5% travel.

This flexible remote or hybrid role is based in Madison, NJ, offering competitive compensation and comprehensive

Join us at Organ Ox as our next Senior Regulatory Affairs Specialist:
SaMD & Med Devices in AL, United States.

If your experience matches this role, we encourage you to apply.

All applications are reviewed carefully by our team.

The position is based in AL, United States.

This opportunity is part of our work in Legal, Management & Operations.

The advertised compensation is 100..

Position Requirements
10+ Years work experience
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