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New hire has more than 25 years of experience in quality assurance and regulatory affairs, with the past 12 years spent at the FDA.
November 18, 2022
By: Michael Barbella
Managing Editor
EMMA International has appointed Dharmesh Patel as vice president of Quality Assurance and Regulatory Affairs. “Dharmesh’s extensive quality assurance and regulatory expertise combined with his FDA tenure will be invaluable asset for EMMA International and our clients,” EMMA International CEO Carmine Jabri, Ph.D., said. Before to joining EMMA International, Patel was assistant director at the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). Within CDRH, he had been with the Office of Regulatory Programs (ORP) since 2019. Patel has led many improvement initiatives for the PMA, 510(k) and Q-Sub programs and has spent more than a decade in various capacities in the PMA Program, from being a policy analyst to a PMA Program lead, and ultimately (after nearly 12 years with the agency) to serve as assistant director. Patel also supported the digital health team when it was first started before moving to ORP. “After many productive years at FDA, I am excited to bring my experiences and what I have learned to EMMA International. Starting at EMMA is a new chapter in my life. I am looking forward to continued growth, to new challenges and opportunities, and meeting and working with a great new team,” Patel said. Patel earned his master’s degree in engineering from Purdue University, an MBA from Walsh College, and a bachelor’s degree in electrical engineering from the University of Cincinnati. EMMA International Consulting Group Inc. provides FDA compliance consulting, focusing on quality, regulatory, and compliance services for the medical device, combination products, and diagnostics industries.
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