CDR Nikhil Thakur, CQA
EPAC Mentoring (Ad-Hoc) Subcommittee Chair
CDR Nikhil Thakur is an Engineer Officer in the United States Public Health Service, and has formerly been the Planning Section Chief and Chief Safety Officer for PHS-1 RDF. At his duty-station (FDA), he is a Senior Program Manager on the Compliance and Quality Staff, and is responsible for leading the development of policies and tools which promote medical device quality. Previously, Nikhil has been the Director for Infusion Pump Program in the CDRH/OPEQ/Office of Health Technology 3 (OHT3). Nikhil has also been a Regulatory Policy Advisor for the Office of Policy for Pharmaceutical Quality (OPPQ), within the Center for Drug Evaluation and Research (CDER), and the Emergency Preparedness, Operations and Medical Countermeasures (EMCM) Program, within the Center for Devices and Radiological Health (CDRH).
Nikhil has had over 18 years of pre-market and post-market experience within the medical device and pharmaceutical workspace, and has been a volunteer contributor to EPAC throughout his career. He has a B.S. in Chemical Engineering from Rutgers University, and comes to the FDA from the Pharmaceutical Industry, where he focused on process and facility design, process scale-up and validation.
Additional Information
Page Last Modified on 1/21/2023
