North Carolina LNG In Person Event- Inside FDA ASCA: Practical Insights

Eric Franca

Director of Conformity Assessment Program, FDA

Eric Franca received his PhD in Biomedical Engineering from the University of Florida where he investigated novel carbon nanomaterials for developing more effective neural electrodes. He began his professional career as a lead reviewer of medical devices at the Food and Drug Administration. He subsequently moved into a policy analyst position managing the content and publication of guidances, orders, and regulations related to medical device review and CDRH policies. He currently serves as Director of the Conformity Assessment Program in his role as an Assistant Director in CDRH’s Division of Standards and Conformity Assessment. Concurrent with his work as a regulator within the FDA, Dr. Franca has participated in standards development, serving in leadership positions within the US National Committee to the IEC and as an US technical expert on several standard development committees.

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Jennifer Coble

MPM, Regulatory Policy Analyst, CDRH Division of Standards and Conformity Assessment - ASCA Program, FDA

No bio provided

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Pamela Gwynn

Principal Engineer in UL Solutions’ CMIT Business Unit, UL Solutions

Pamela Gwynn is a Principal Engineer in UL Solutions’ CMIT business unit, with global technical leadership responsibilities for Medical Electrical Equipment (IEC/UL 60601 and 80601 series), Personal Health and Hygiene Appliances, and a broad range of healthcare‑related technologies. With more than 38 years of experience in product safety, Pamela brings deep expertise in medical electrical devices, home healthcare products, and household appliance categories—offering a uniquely comprehensive perspective on emerging consumer‑health technology.

Pamela was inducted in 2023 as a UL Corporate Fellow within the William Henry Merrill Society—the highest lifetime recognition awarded by UL Solutions for distinguished technical achievement and contributions to public safety. As a Corporate Fellow, she provides strategic engineering and scientific guidance in areas including research, technical workforce development, mentorship, and stewardship of UL’s technical legacy.

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Rohan Shah

 Co-Chair and Vice-President, RAPS North Carolina Local Networking Group 

Rohan Shah is the Associate Director of Regulatory Affairs Advanced Repair and Reconstructions, Surgery at BD (Becton, Dickinson and Company), with a broad cross-functional background in Medical Devices spanning over 18 years.

Rohan has deep experience across  high‑risk implantable products and innovation programs. He has held regulatory roles of increasing responsibility, bringing a strong understanding of EU MDR, FDA pathways, clinical evidence, and post‑market requirements to enable efficient and compliant global market access.

Rohan’s regulatory career was shaped by formative early years in R&D and product development at Covidien and Teleflex, where he worked across technology development, design controls, and manufacturing transfer. His transition into Regulatory Affairs began at the BSI Notified Body, where he served in technical and scheme leadership roles—experience that continues to inform his patient safety and clinical efficacy approach to regulatory strategy.

Rohan holds a Bachelors of Science in Biomedical Engineering from The City College of New York and a Masters in Science from The University of Connecticut.

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