Susumu Nozawa, RAC, FRAPS – Chairman of the Board
Susumu Nozawa is Director, Technical & Regulatory Policy at Corporate Regulatory Affairs at BD in Franklin Lakes, New Jersey. He is responsible for establishing and implementing a global technical and regulatory policy management program within BD and communicating significant and actionable technical and regulatory policy information to the senior management. In his career, he has held various positions in R&D, Regulatory Affairs and Compliance, and Quality Assurance for global operation. Currently Mr. Nozawa serves as the industry chair of AdvaMed Japan Subcommittee Working Group on Japan Regulatory Affairs and Compliance, a Leadership Team member of the American Medical Devices and Diagnostics Manufacturers’ Association Regulatory Affairs/Quality Assurance (AMDD RAQA) Group, based in Tokyo, and President (2017)/in-coming Chair (2018) of RAPS.
Don Boyer, BSc, RAC, FRAPS – President
Don Boyer is the owner and president of BOYER@RegulatorySolns, providing regulatory services to the health products industry. Previously he held senior management positions with Health Canada including the Medical Devices Bureau, Establishment Licensing for drugs and medical devices and the Bureau of Product Review and Assessment for natural health products. His career with Health Canada spanned 32 years with more than 25 years of regulatory affairs experience. He also has been active in initiatives such as the Global Harmonization Task Force, International Medical Device Regulators Forum and cooperative agreements with other international regulatory authorities. He holds the RAC credential, is a RAPS Fellow and has served as a member and chair of the Canadian RAC exam committee.
Glenn N. Byrd, MBA, RAC – President-Elect
Glenn N. Byrd is a senior director, promotional regulatory affairs, at AstraZeneca. He has more than 27 years of regulatory experience including 10 years at the US Food and Drug Administration. Byrd’s industry experience has focused on advertising and promotional compliance, regulatory strategy, clinical trial design and management of consulting firms and CROs, combination products, and medical devices. He holds a BS in Aerospace Engineering from Va Tech and an MBA from Hood College.
Salma Michor, PhD, MSc, MBA, CMgr, RAC – Treasurer
Salma Michor is founder and CEO of Michor Consulting e.U, serving such clients as Johnson & Johnson, Novartis, Valeant Pharma and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. Michor is a member of the RAPS European Advisory Committee. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King’s College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU).
Paul Brooks – Executive Director
Paul Brooks has more than 25 years of work experience within the medical device regulatory affairs environment during his 35-year career with the British Standards Institution (BSI), where he served most recently as senior vice president, BSI Americas Healthcare and previously was head of the medical device EU Notified Body responsible for review and clearance of medical devices against European regulations. He also led BSI in achieving formal recognition as a recognized third party under FDA’s Center for Devices and Radiological Health (CDRH) and Health Canada’s Canadian Medical Devices Conformity Assessment System (CMDCAS) programs, and he is known both domestically and internationally as an expert on medical device regulations and regulatory issues.
Gert Bos – Director
Gert Bos is executive director and partner with Qserve Group. He is an expert in European regulations with 15 years of experience as auditor, product reviewer, regulatory specialist and head of Notified Body. Bos has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He has a PhD in biomaterial sciences, and post-doctoral degrees in controlled release of drugs and gene therapy. He is a RAPS Fellow.
David E. Chadwick, PhD, RAC, FRAPS – Director
David E. Chadwick is director of regulatory affairs and regulatory science for Cook Inc. In this role, he provides high-level regulatory and clinical advice on pre- and postmarket safety, quality, performance testing, compliance and marketing issues pertaining to the manufacture and supply of medical devices globally. Dr. Chadwick has more than 25 years of experience in the medical device industry, including many years in research and development functions and managing clinical trials prior to transitioning into regulatory affairs. He is an adjunct professor of biology at Bethel College in St. Paul, MN, USA, and adjunct faculty at Ivy Tech College in Bloomington, IN, USA.
Raina Dauria, MS, RAC – Director
Raina Dauria is senior director of regulatory affairs for Ethicon Biosurgery, a platform within Ethicon Inc. Prior to joining Ethicon in 2011, Dauria worked for Advanced Technologies and Regenerative Therapeutics LLC., part of the Johnson & Johnson family of companies, with experience spanning from pre-approval regulatory submissions for device, biological and combination products to oversight of clinical research, field scientific affairs and quality assurance. Dauria received her master’s of science in drug regulatory affairs and health policy from Massachusetts College of Pharmacy, Boston. She also holds the RAC credential.
Jethro Ekuta, DVM, PhD, RAC, FRAPS – Director
Jethro Ekuta is vice president and head of regulatory affairs North America, Johnson & Johnson Consumer Inc. In this role, he drives regulatory innovation and develops regulatory strategies and their execution for the R&D pipeline across the entire consumer product portfolio encompassing all need states and product classifications (drugs, medical devices, cosmetics and commodities) in North America. Ekuta has also served in executive-level regulatory affairs positions at Genzyme, Bristol Myers Squibb Company, Wyeth Research, Pfizer Global Research and Development and Procter & Gamble Pharmaceuticals. Prior to that, he was special government employee and fellow in clinical pharmacology in the US Food and Drug Administration’s Office of Clinical Pharmacology and Biopharmaceutics.
Laila Gurney, MSc, RAC – Director
Laila Gurney is the head of global regulatory affairs at GE Healthcare, where she leads the regulatory affairs function in developing competitive global go-to-market strategies that align with business priorities, and ensures postmarket regulatory compliance. Prior to this, she held leadership roles within GE Healthcare, including as regulatory leader for GE Healthcare's imaging business, MICT & DGS businesses and the Central and Canadian RA organizations. Gurney also has served as national director, regulatory and quality at Cardinal Health Canada and director of clinical, quality and RA for PreMD Inc. She served on the Global Harmonization Task Force Study Group 3 (Quality Systems) as secretary from 2009 to 2012. She holds the US and EU RAC credentials.
Michael C. Morton – Director
Michael C. Morton is vice president for corporate regulatory affairs at Medtronic Inc. He is responsible for public health policy advocacy in regulatory affairs, and for internal regulatory policy. Morton has more than 30 years of experience in the medical device industry, including quality, clinical and regulatory affairs. Before Medtronic, he worked with CarboMedics Inc., W.L. Gore and Associates, Alcon Labs, and Sorin Group. He is a RAPS Fellow, and is active in industry groups, including the Advanced Medical Technology Association (AdvaMed). He co-chairs the AdvaMed PMA Working Group, and the Pediatric Devices Working Group, and is a member of the Heart Valve Task Force. He represented industry within Study Group 1 (Premarket) of the Global Harmonization Task Force.
Nancy Singer, JD, LLM, RAC, FRAP – Director
Nancy Singer founded Compliance-Alliance LLC in 2004 to specialize in the professional development for government, association, and business professionals. She is on the faculty of George Washington University School of Medicine and Health Sciences, and she has taught classes at Johns Hopkins University, University of Southern California, and Harvard Symposia. She presently teaches classes for FDA Staff Colleges and FDA District Offices. Previously she served as Special Counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. She began her career as an attorney with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker. Nancy is a retired commander in the Naval Reserve.
Susan Stewart, JD, RAC, FRAPS – Director
Sue Stewart has more than 27 years of regulatory affairs and quality assurance experience in the development and commercialization of drugs, biologics and devices intended to treat conditions considered unmet medical needs. She is currently president of Stewart Regulatory Consulting LLC. Prior to that, she was senior vice president of regulatory, quality and compliance at Tokai Pharmaceuticals, and before that, served as vice president of regulatory affairs at TransMolecular Inc. Stewart also spent 14 years in regulatory at Genzyme Corporation, serving in multiple roles, and she began her career in regulatory and quality at Abbott Laboratories. She holds a JD from Concord Law School, is a RAPS Fellow and holds both the US and EU RAC credentials.
Edward Tabor, MD – Director
Edward Tabor is vice president, regulatory affairs North America, at Fresenius Kabi, a leading manufacturer of intravenous nutrition products. Previously, he was vice president, strategic drug development, and vice president, global regulatory affairs at Quintiles and had been a division director of two FDA divisions. Tabor is the author of more than 300 publications on viral hepatitis, other infections transmitted by blood, liver cancer and regulatory affairs, including Risk Evaluation and Mitigation Strategies for US Drug Development published by RAPS in 2012. He holds an MD from Columbia University.