Medical Device Regulatory Review Specialists

The Medical Device Regulatory Review Specialists subcontract supports the FDA Center for Devices and Radiological Health by providing expert regulatory review of medical device marketing applications. The scope of work includes evaluating 510(k), PMA, and De Novo applications, as well as processing Presubmissions and Emergency Use Authorizations. Selected personnel must possess deep expertise in regulatory science and medical device approval processes to deliver comprehensive written reviews and submission evaluations while adhering to strict conflict of interest and ethics training requirements. Managed by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services, this opportunity is categorized under NAICS code 541620. The work is performed in Silver Spring, Maryland. Interested parties must respond by November 17, 2026, following the posting date of October 30, 2026.