Kenneth J. Cavanaugh Jr., PhD has been employed at the U.S. Food and Drug Administration Center for Devices and Radiological Health since 2003 and is currently the Center’s Associate Director for International Policy and Strategy. His contributions to the Center’s international harmonization and convergence efforts include serving as a co-chair of the IMDRF Good Regulatory Review Practices Working Group and as a technical expert for ISO standards development activities involving general considerations for medical devices. Prior to his current role, he worked in FDA’s Office of Cardiovascular Devices as part of the management team responsible for overseeing pre-market review, post-market surveillance, and compliance-related activities for all cardiovascular devices in the United States.