Robin Newman joined FDA in February 2016 as Director, Office of Compliance at CDRH. She has 20+ years of senior level clinical/regulatory and compliance management in new product research and development. Ms. Newman’s experience includes senior level consulting for regulatory strategy, clinical trial design and execution, standards and SOP development, quality system management and compliance, clinical & medical writing, customer/public interface and education, and management of Data Safety Monitoring Boards and Clinical Event Adjudication Committees. Most recently, Ms. Newman served as the Vice President of Quality Management for Siemens Healthcare Diagnostics, where she managed a multidisciplinary quality management team and functioned as the primary representative for AdvaMedDx and the Diagnostic Tests Working Group. She holds a B.S. and M.S. in Nursing from the University of Texas, an Ed.D. from The George Washington University’s Executive Leadership Program, and holds certifications as a Pediatric Nurse Practitioner, in regulatory affairs (RAPS), and in as a CCRA (ACRP).
Events Robin Newman will be attending: