Medical Device Senior Operations Officer
Current- Serves as a technical authority and subject matter expert on the interpretation and application of regulatory policy.- Conducts inspections and investigations related to the most complex, controversial, and precedent-setting scientific and regulatory issues facing the medical device program.- Leads the development and presentation of national/international training programs and materials in medical devices and radiological health.- Develops and recommends new and revised guidelines for investigative techniques and proposes areas of study for new and revised policy and guidelines as related to ORA investigations.- Represents the FDA and the Office of Medical Devices and Radiological Health Operations.