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.

: ericfranca

Clarissa Benfield

Global Business Director, Intertek ETL

Clarissa is the Global Director and Business Leader for Medical, Laboratory, and Life Safety &
Security at Intertek. With nearly 20 years of experience in the Assurance, Testing, Inspection,
and Certification (ATIC) industry, Clarissa has built her career helping organizations navigate
complex regulatory, quality, and safety requirements while accelerating innovation and market
access. Dedicated to Intertek's mission of bringing quality, safety, and sustainability to life,
Clarissa leads global teams that support manufacturers across the medical, laboratory, and life
safety sectors. She works closely with companies developing cutting-edge technologies and life-
changing products, helping them meet evolving standards, demonstrate compliance, and
deliver trusted solutions to customers worldwide. She is passionate about fostering
collaboration across the healthcare and life safety ecosystem and enabling the successful
commercialization of technologies that improve lives, enhance safety, and advance public well-
being.

: clarissa-benfield-8a024730

Maria Baker

Business Development Manager, UL Solutions

Maria Baker, is a Business Development Manager at UL Solutions with global leadership responsibilities. She contributes to the public health and safety mission by helping innovators bring cutting-edge medical technologies to market. Maria specializes in developing efficient global regulatory strategies, including support for the FDA ASCA program.

Maria holds a Bachelor of Science in Electrical Engineering from Cleveland State University and is an advocate of STEM education and leadership development. She remains dedicated to improving public health and safety by partnering with manufacturers, policymakers, and regulators to bring next-generation medical technology to market.

: mariabakerbsee

Utpal Banik

Lead Auditor, TÜV Rheinland of North America Inc.

Utpal Banik, PhD, is an experienced Quality and Regulatory professional with 20+ years of experience in the Medical Device industry, with a strong commitment to advancing quality, safety, compliance, and patient well-being. He brings extensive expertise in Quality Management Systems, Regulatory Compliance, Risk Management, Medical Device Software, Cybersecurity, and Post-Market Surveillance.

His areas of expertise include FDA 21 CFR 820, EU MDR/IVDR (2017/745; 2017/746), ISO 13485, ISO 14971, IEC 62304, MDSAP, Design Controls, Computerized System Validation, SaMD, PCCP, CAPA/NCR/SCAR, Supplier Quality, Manufacturing Process Validation, Design Transfer, Vigilance System and Audits. 

: utpalbanik

Jon Gawlak

Technical Manager/Senior Auditor, SGS North America

Over 35 years of Quality and Project Management Experience with over 29 years of Leadership Experience in the Pharmaceutical, Cosmetic, Personal Care, Food, and Medical Device Industry

Specialties: QA, QC, Supplier Qualification and Management, CMC, Quality Management, Project Management, Certification Auditing, Vendor Auditing, Internal Auditing, Analytical Testing, QC Laboratory Management

: jongawlak

Dara Wambach, MA

Executive Director of Regulatory Affairs, Mirum Pharmaceuticals

Dara Wambach, MA, is Executive Director of Regulatory Affairs at Mirum Pharmaceuticals and a regulatory and R&D leader with more than 20 years of experience advancing therapies from early development through commercialization. Her experience includes regulatory leadership roles across small and mid-sized Bay Area biotechnology companies, including more than a decade at Gilead where she led the U.S. regulatory submission and FDA review for the first HIV pre-exposure prophylaxis (PrEP) indication for Truvada.

Dara has contributed to pediatric development programs in HIV, sickle cell disease, and narcolepsy, as well as programs addressing pulmonary and liver diseases. At Janssen Global Public Health R&D, she developed and led Johnson & Johnson’s two-year R&D Fellowship Program with the Institute of Tropical Medicine Antwerp for scientist-physicians from Africa. She is also a member of the RAPS San Francisco Bay Area Chapter Leadership Team and serves as Chair of the Sponsorship Committee.

: dara-wambach