Dave is a seasoned regulatory expert with extensive proficiency in U.S. medical device regulations. His regulatory career began in 2009 at the FDA where he dedicated 7 years to the premarket orthopedic devices branch. Dave held pivotal roles including acting branch chief of the orthopedics branch and senior premarket lead reviewer. Departing the FDA in March 2016, Dave transitioned to MCRA, where his regulatory has been further strengthened working with novel and innovative technologies and companies. Since joining MCRA, Dave has spearheaded a multitude of regulatory projects, focusing primarily on U.S. regulatory affairs with a specialized emphasis on orthopedic joint arthroplasty, trauma, sports medicine, navigation, robotics, wound management, and plastic and reconstructive devices. Throughout his career, Dave has reviewed and crafted hundreds of regulatory submissions, encompassing 510(k)s, PMAs, De Novos, IDEs, and HDEs. He works with others within MCRA to develop and execute innovative strategies for bringing medical devices through the FDA. Dave led the MCRA team in an orthopedic De Novo which was the first orthopedic De Novo granted by the Agency. It is through his strategic and practical approaches that his clients can succeed. With expertise and knowledge of how FDA operates, he is able to anticipate questions and potential hurdles while developing reasonable solutions to achieve regulatory approvals.