Board of Directors
Don Boyer, BSc, RAC, FRAPS – Chairman of the Board
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
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.
Gert Bos, PhD, FRAPS – President Elect
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.
Salma Michor, PhD, MSc, MBA, CMgr, RAC – Treasurer
Salma Michor is founder and CEO of Michor Consulting and Trade Services GmbH, 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.
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.
Carol Cooper, MS, IM(ASCP), RM(AAM) – Director
Carol Cooper is founder and principal of CM Cooper and Associates, specializing in clinical and regulatory affairs. Her career in the healthcare industry began at Abbott Diagnostics as an HBV researcher, moving into multiple positions in clinical and regulatory affairs. Cooper’s regulatory experience is primarily in medical devices, IVDs, biologics and combination products with a special emphasis on advertising and promotion. She holds a master’s in Pharmacy from Temple University in RAQA as well as the RAC (US) credential. Cooper has been an active RAPS volunteer and has served as leader and co-leader of the RAPS Chicago Chapter and member of the Regulatory Affairs Certification Board.
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 Senior Vice President, Global Head of Regulatory, Safety & Standards at Horizon Pharma. Previously, he was vice president and head of regulatory affairs North America, Johnson & Johnson Consumer Inc., where he drove regulatory innovation and developed 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, and cosmetics) 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 joining industry, 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, RAC, FRAPS - Director
Michael C. Morton is principal of Michael C. Morton Regulatory Consulting LLC. He has more than 30 years of experience in the medical device industry, including quality, clinical, and regulatory affairs. Morton was previously vice president for corporate regulatory affairs, at Medtronic Inc. Before joining Medtronic, he worked for CarboMedics Inc., W.L. Gore and Associates, Alcon Labs and Sorin Group. Morton has been active in industry groups, including the Advanced Medical Technology Association (AdvaMed), where he chaired the AdvaMed PMA Working Group and the Pediatric Devices Working Group, and was a member of the Heart Valve Task Force. He represented industry within Study Group 1 (Premarket) of the Global Harmonization Task Force and remains interested in current harmonization activities. He also served as the industry representative to the FDA Circulatory System Devices Advisory Panel and received the FDA Advisory Committee Service Award.
Diana K. Salditt, FRAPS – Director
Diana Salditt leads the regulatory advocacy and policy group at Medtronic, working with Medtronic geographies and businesses and with external organizations to advocate for regulation that promotes and protects public health, and supports patients and other stakeholders. She is a RAPS Fellow and has a broad range of product and regulatory experience, including US and international regulatory submissions and compliance for combination products, medical devices, drugs and biologics. Salditt is active in organizations including device industry trade associations and the Medical Device Innovation Consortium. Prior to her current position, she held a variety of regulatory positions in Medtronic’s neurological and cardiac surgery businesses and in the in vitro diagnostics industry.
Nancy Singer, JD, LLM, RAC, FRAPS – 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
Susan Stewart has served as Kaleido's Senior Vice President, Regulatory Affairs & Quality since April 2018. Ms. Stewart has worked for more than 27 years in biopharmaceutical regulatory affairs, with significant experience devising innovative strategies for novel therapeutics, overseeing regulatory submissions at various stages of product development and leading interactions with global health authorities. Previously, in addition to being an independent regulatory consultant for several years, she was senior vice president of regulatory affairs, quality, and compliance at Tokai Pharmaceuticals and vice president, regulatory affairs at Transmolecular. She also spent more than 13 years at Genzyme Corporation in regulatory and compliance roles, including serving as vice president, regulatory affairs. She received her J.D. from Concord Law School at Purdue University Global and her B.A. from the University of Massachusetts. She holds both US and EU RACs.