Speakers & Moderators

Executive Director & Partner at Qserve Group

Gert Bos is an expert in European regulations based on his hands-on work in the field as auditor, product reviewer, regulatory specialist, and Head of notified body. He has led the Notified Bodies in Brussels for many years, and strongly supported the regulatory debate with the EU Commission, EU Parliament, and the EU Council of Ministers. Bos combines strong experience in quality, compliance, and regulations with a pragmatic, result-driven approach at both operational and strategic levels.

Director for the Office of Regulatory Programs Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)

RADM Sean M. Boyd serves as the Director for the Office of Regulatory Programs in FDA’s Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ). In this capacity, he is responsible for managing the Center’s review programs that ensure the public has access to high-quality, safe, and effective medical devices.

Assistant Director, Establishment Assessment Team 1, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)

Gina Brackett is the Assistant Director, Establishment Assessment Team 1, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH), FDA. She has been with the FDA for over 30 years. Prior to her current position, she served as a Compliance Officer in the Cincinnati District Officer for 15 years. She was a Medical Device Specialist for seven years and during this time was certified as a Level II Performance Auditor and conducted numerous complex medical device inspections. Brackett is a member of numerous workgroups and has helped develop new procedures to assure a smooth transition since ORA’s program alignment in May of 2017.

Senior Director of Regulatory Affairs

Bill Brodbeck is Senior Director, Regulatory Affairs at STERIS Corporation in Mentor, Ohio. He shares the responsibility for FDA submissions and interactions while helping to maintain compliance with FDA requirements, guidance, and processes. Brodbeck is involved with several of the STERIS business units including medical device manufacturing, instrument repair, and industrial contract sterilization, providing regulatory expertise to each.

VP of Quality Systems & Post Market

Aaron Dunbar is VP, Quality Systems & Post Market, Boston Scientific. He has 20 years of comprehensive experience driving regulatory compliance and quality system regulations and standards across the medical device and healthcare industries. Dunbar is an active member of the Association for the Advancement of Medical Instrumentation (AAMI) Quality Management standards committee and working groups. He has previously held roles at Boston Scientific Corporation, Tornier, Inc., and was a Medical Device Specialist and Investigator for the U.S. Food and Drug Administration – Minneapolis District Office.

Consumer Safety Officer, Special Assistant, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)

Susan Matthias is a Consumer Safety Officer, Special Assistant in Office of Medical Device and Radiological Health Inspectorate (OMDRHI). She is responsible for assisting the office director with a wide variety of coordination and administrative projects, managing the OMDRHI strategic direction, and providing expertise as a subject matter expert. Prior to this position, she was a Device Specialist for eight years in OMDRHI’s central division, and maintains her Level II certification. She has worked for FDA since 2008. Prior to joining FDA, Matthias was the manufacturing manager for a mid-size medical device firm, where she managed production supervisors and manufacturing operations personnel. She also held various engineering and project management roles at industrial and automotive firms.

Medical Device National Expert, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)

Phillip Pontikos is a Medical Device National Expert working for the Office of Regulatory Affairs (ORA) of the Food and Drug Administration. He joined FDA in 1994 as an Investigator in the Brunswick, Ohio, Resident Post of Cincinnati District. In 2000, Pontikos moved to Columbus, Ohio, where he currently resides. Pontikos is responsible for conducting medical device inspections domestically and abroad; he is a Level II Certified Medical Device Investigator and Medical Device Performance Auditor. Pontikos has assisted in the development of and actively participates as a trainer for numerous FDA courses including Computer Aided Inspections, Basic Medical Device, Industrial Sterilization for Drugs/Devices, and Process Validation. He has also served as a mentor and acting Supervisor.

Director of Regulatory Policy, International and Harmonization

As part of Medtronic’s global regulatory policy team in Washington, D.C., Fatemeh Razjouyan is actively shaping the global regulatory landscape to promote harmonization. She represents Medtronic in industry working groups and coalitions to advance its goal of providing patients with safe and innovative therapies. Razjouyan was previously the head of U.S. regulatory policy in B.D. Prior to that, she held various roles in the Center for Devices and Radiologic Health (CDRH) at the U.S. Food and Drug Administration (FDA). From 2013 to 2018, she led the 510(k) review program in the Office of In Vitro Diagnostics and Radiological Health (OIR) in CDRH, where she trained review staff, drafted guidance documents and work instructions, and assisted in the implementation of the Medical Device User Fee Amendments (MDUFA) and regulatory policy for the 510(k) program.

Executive Vice President of Medical Devices & Combination Products

Heather Rosecrans brings more than 40 years of public health, and particularly medical device experience, to MDMA and ELIQUENT Life Sciences. Prior to joining MDMA and ELIQUENT, Heather spent 33+ years at the U.S. FDA’s Center for Devices and Radiological Health (CDRH). Heather served for her last 18 years at CDRH as Director of the Premarket Notification (510(k)) Staff. In this role, she was responsible for implementing administrative and regulatory policy for the 510(k) Program, the 513(g) Program, Classification and Reclassification, de novo petitions and other premarket regulatory requirements.

Kim Shoemaker is an accomplished Global Regulatory Affairs Leader with more than 25 years’ experience in the healthcare industry. As a Senior Director at Ethicon, part of the Johnson & Johnson Medical Devices Companies, she is known for her ability to accelerate regulatory approvals and provide alternative pathways to business partners to achieve their business goals, while maintaining compliance with required regulations. With extensive global experience, she drives innovative multi-country regulatory strategies that lead to timely market entry and drive industry-leading outcomes that enable growth and advancement of patient care around the world.

Medical Device, IVD and Combo Product Expert

Kim Trautman, former Associate Director of International Affairs at FDA, is an experienced medical device, IVD, and combination product expert with over 30 years of industry and regulatory agency experience. An expert in global medical device regulations, she wrote and harmonized the current FDA Quality System Regulation. Trautman was also on the FDA authoring committee for 21 CFR Part 4 and FDA Combination Product GMP guidance documents. In addition, she developed the International Medical Device Single Audit Program (MDSAP) and consortium from conception through its pilot. Trautman is a 25-year veteran of the Global Harmonization Tasks Force (GHTF) and a foundational member of the International Medical Device Regulators Forum (IMDRF).

Monica Wilkins joined Abbott in 2007, where she provides strategic support and technical expertise to the medical device divisions within Abbott. Prior to joining Abbott, she worked for the Food and Drug Administration (FDA). In her 12 years of FDA-related experience, Wilkins held the positions of Medical Device National Expert, Compliance Officer, Medical Device Specialist, and Investigator. Before joining FDA, Wilkins’ career included 14 additional years of employment in the regulatory, computer, healthcare, and pharmaceutical industries in positions including Research Assistant, Quality Control Technician, Microbiologist, Supervisor, Manager, Specialist, Director, and Consultant.

Vice President of Quality, Regulatory, Environmental, and Public Affairs Counsel

Jessica Zeller is Vice President – Quality, Regulatory, Environmental, and Public Affairs Counsel at Edwards Lifesciences based in Irvine, California. Zeller is a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. She routinely counsels on global medical device regulatory compliance matters and quality systems concerns, including interacting with government regulators. She was previously FDA’s inaugural ORA Ombudsman, focusing on problem-solving with respect to FDA’s field offices, including inspections, imports, and other agency processes and procedures. Additionally, Zeller has served as the Deputy Director of Compliance and Enforcement for FDA’s Center for Tobacco Products, as a litigation attorney in FDA’s Office of Chief Counsel, and as the lead FDA lawyer for Procter & Gamble.