Dr. Kenneth J. Cavanaugh Jr. has been employed at the U.S. Food and Drug Administration Center for Devices and Radiological Health since 2003 and is currently a Deputy Director in FDA’s Office of Cardiovascular Devices.  In this role, he is 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.  Dr. Cavanaugh has also worked extensively in the areas of standards and guidance development and international harmonization, including co-leading several International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices Working Group activities, supporting other IMDRF Working Groups and GHWP WG1, and contributing to ISO work items involving general aspects of medical devices and cardiovascular device evaluation.  From 2016 – 2017, he relocated to Japan on an external fellowship and partnered with multiple Japanese healthcare-related government agencies and non-government organizations to further promote global regulatory collaboration and medical device development.