International Medical Device Regulatory & Compliance Specialist

This subcontract opportunity is for an International Medical Device Regulatory and Compliance Specialist to support prime contractors on GO-Biz medical device export projects. The selected provider will perform specialized regulatory analysis, focusing on international classification, registration, and labeling requirements. Key responsibilities include mapping FDA 510(k), PMA, and Quality System Regulation pathways to their foreign equivalents, evaluating post-market surveillance requirements, and delivering comprehensive market-fit assessments and regulatory feasibility analyses. The project is managed under the California Business and Economic Development agency with a NAICS code of 541611. Interested parties must submit their responses by the deadline of October 30, 2026.