Jim Rosa

Biography

Jim Rosa provides AI Regulatory Strategy and SaMD training and guidance to companies for the development, management and operation of regulated devices. He has 40 years of experience leading R&D, Regulatory and Compliance functions within high-tech and regulated industries. With roots in research and development and conversion to regulatory and compliance oversight strategy, Jim provides a solid understanding and perspective from engineering and regulatory in bringing products to market in the medical device and IVD industries. The blend of working with research & development and regulatory function, worldwide, in startups and large companies provides a unique insight into the practical application of bringing AI based medical devices to market. Jim also has four patents related to medical device safety system implementations. Jim has worked for Gambro, Intel, Reglera and several early stage and start-up companies. 

Jim’s recent focus has been on AI Strategy for Systems & Software within the medical device market, driving strategy and implementation efforts for bringing these novel devices to market. Additionally, Jim has taught Design Controls, V&V, and Risk Management at the University level.

Mr. Rosa has earned degrees from Colorado State University (MBA) and Radford University (BSCS).