Cesar A. Perez, CQA, RAC, Ph.D., is the director of the Division of Establishment Support, Office of Regulatory Programs (ORP), and Center for Devices and Radiological Health (CDRH) for the FDA. As director, Perez provides strategic leadership to the division and serves as the technical authority and principal advisor to the office director on multiple medical devices programs. The division is responsible for the development and implementation of policies and processes related to medical devices’ imports, registration and listing, exports, regulatory inspections/audits and compliance programs.