Senior Regulatory Affairs Specialist – SaMD/SiMD, Remote
Madison, Morris County, New Jersey, 07940, USA
Listed on 2026-10-06
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Quality Assurance - QA/QC
Organ Ox is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America and oversee quality-related compliance. You will collaborate with multiple teams to ensure SaMD/SiMD products meet FDA and Health Canada requirements, including IDEs, PMAs, and PMA supplements.
The role supports regulatory change assessments, keeps abreast of standards, and may involve domestic and international travel. A Bachelor's degree in engineering or life sciences is required.
This is a genuine role to take on the Senior Regulatory Affairs Specialist – SaMD/SiMD, Remote role at Organ Ox.
If your experience matches this role, we encourage you to apply.
All applications are reviewed carefully by our team.
The position is based in Madison, NJ, United States.
This opportunity is part of our work in Legal, Management & Operations.
The advertised compensation is 120..
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