Remote Regulatory Affairs Specialist — SaMD & FDA ; k) Expert
New York, New York City, Richmond County, New York, USA
Listed on 2026-10-26
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Healthcare
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Quality Assurance - QA/QC
Location: New York
GXPeople Global Ltd. is seeking an experienced Regulatory Affairs Specialist for a permanent, 100% remote role. You will drive regulatory strategy and global compliance to enable market access for cutting-edge devices, including SaMD, across regions.
You will manage EU MDR and FDA 510(k) submissions, create essential documentation, and guide cross-functional teams to integrate regulatory requirements into development. Experience with ISO standards and imaging modalities is preferred.
The Remote Regulatory Affairs Specialist — SaMD & FDA 510(k) Expert role at GXPeople Global Ltd. is now open for applications in United States.
We are looking to fill the Remote Regulatory Affairs Specialist — SaMD & FDA 510(k) Expert position at GXPeople Global Ltd. in United States.
Join us at GXPeople Global Ltd. as our next Remote Regulatory Affairs Specialist — SaMD & FDA 510(k) Expert in United States.
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