Dr. Carole C. Carey

Biography:

Carey went to the FDA in 1990 to join the medical device program and participate in national and international standards development programs for medical equipment. As a senior regulatory engineer, she reviewed the safety and effectiveness of technologically complex cardiac devices before they were allowed to reach the market. In 2003, she was selected with six other outstanding U.S. government employees from different federal agencies to participate in the Mike Mansfield Fellowship program, a two-year, government-to-government exchange between the United States and Japan where she gained a deeper understanding of regulatory processes and built networks of contacts in Japan's Ministry of Health, Labour and Welfare and the Ministry of Economy, Trade and Industry. Currently, Carey is the Director of International Affairs in FDA's Center for Devices and Radiological Health where she coordinates international relations activities, works on global harmonization, regulatory convergence issues, standards development and communications.