BINGHAM FARMS, Mich.–(BUSINESS WIRE)–EMMA International, a global leader in Quality and Regulatory consulting, announced today the appointment of Dharmesh Patel, MBA, PMP, GWCPM, CSSGB as Vice President of Quality Assurance and Regulatory Affairs.
Prior to joining EMMA International, Mr. Patel served in the capacity of Assistant Director at CDRH [Center for Devices and Radiological Health] at FDA. Within CDRH, he had been with the Office of Regulatory Programs (ORP) since 2019. Mr. Patel has been leading many improvement initiatives for the PMA, 510k and Q-Sub programs and has spent over 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 in the role of Assistant Director.
“Dharmesh’s extensive quality assurance and regulatory expertise combined with his FDA tenure will be an invaluable asset for EMMA International and our clients,” said Carmine Jabri, PhD, EMMA International’s Chief Executive Officer.
“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,” Dharmesh Patel.
Mr. Patel also supported the Digital Health Team when it was first started before moving to ORP. He received 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.
About EMMA International
EMMA International is a leading global consulting firm for the medical device, pharmaceutical, biotechnology, combination products, and diagnostics industries. With a focus on quality, regulatory and compliance services, EMMA International helps ensure your products advance seamlessly from concept to approval. For more information, visit http://www.emmainternational.com/.