Board of Directors

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, MBA, is president of GByrd AdPromo Solutions LLC., a consulting company focused on providing expert advertising and promotion regulatory support to the biopharmaceutical industry. Byrd previously headed the AstraZeneca oncology promotional regulatory affairs team for more than 11 years. He has held numerous regulatory leadership roles over his 29-year career in regulatory affairs, with experience working for government, industry, consulting firms and clinical research organizations. Byrd spent 10 years at FDA, including six years in the Center for Devices and Radiological Health as a device reviewer and four years in the Center for Biologics Evaluation and Research as head of the Advertising and Promotional Labeling Branch. He received his 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 26 years of experience in life sciences, including 15 years 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 postdoctoral degrees in controlled release of drugs and gene therapy. He is a RAPS Fellow, a founding member of the RAPS European Council and a founding board member of the RAPS Netherlands Chapter.

David E. Chadwick, PhD, RAC, FRAPS – Treasurer
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 for medical devices. Chadwick has more than 25 years of experience in the medical device industry, including many years in research and development, and clinical trials management prior to transitioning into regulatory affairs. He serves as the industry representative on the FDA CDRH advisory panel on ear, nose and throat devices. Chadwick also is an adjunct professor for Purdue University, Bethel College in St. Paul, MN, and Ivy Tech College in Bloomington, IN, and serves on the advisory board for George Washington University’s regulatory affairs program.

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.

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 MS, RAC is worldwide vice president of regulatory affairs for the Cardiovascular and Specialty Solutions franchise within the Johnson & Johnson Family of Companies. Previously, she was senior director of regulatory affairs for Ethicon Biosurgery. Prior to joining Ethicon in 2011, Dauria worked for Advanced Technologies and Regenerative Therapeutics LLC., part of Johnson & Johnson, 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, global regulatory affairs at Alexion Pharmaceuticals Inc. Previously, he was senior vice president, global head of regulatory, safety and standards at Horizon Pharma. Prior to that, he was vice president and global head for multiple franchises and regional head of regulatory affairs North America, Johnson & Johnson Consumer Inc. At J&J, Ekuta drove regulatory innovation and developed regulatory strategies and their execution for the R&D pipeline across the entire consumer product portfolio. He 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. He was also a special government employee and fellow in clinical pharmacology in FDA’s Office of Clinical Pharmacology and Biopharmaceutics.

Laila Gurney, MSc, RAC – Director
Laila Gurney is senior executive, global quality and regulatory 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. She also leads the complaint handling unit, postmarket and central quality teams. 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 as secretary on the Global Harmonization Task Force Study Group 3 (Quality Systems), and holds the US and EU RAC credentials.

Sabina Hoekstra-van den Bosch, PharmD FRAPS – Director
Sabina Hoekstra is founder and principal of EUMD Consultancy, specializing in regulatory advice to the health products industry. She has 20 years of experience as pharmaceutical and medical device regulator in the Dutch government, serving subsequently in the Medicines Evaluation Board, Ministry of Health and CCMO (governmental organization for clinical investigations). Hoekstra has worked as lead for European Regulation at Philips and was involved in Philips’ EU MDR/IVDR implementation program. She was vice chair of the EU Regulatory Affairs Focus Group and Chair of the Clinical Working Group in COCIR and member of regulatory affairs committee in MedTech Europe. She was co-founder and chair of the RAPS Netherlands Chapter and is a RAPS Fellow.

Frank Pokrop, RAC, FRAPS, CQE, CISA – Director
Frank Pokrop has worked in the medical device arena for more than 20 years and currently is the senior director for regulatory affairs and quality assurance Sotera Wireless in San Diego. His prior experience covers manufacturing quality assurance for large and small volume parenteral drugs. In one role with a Fortune 100 company, Pokrop was the formal liaison to FDA and worldwide health agencies. He has been an active volunteer, including as a member of MD&DI's editorial advisory board, an officer of the San Diego Regulatory Affairs Network, and a member of the “B” IRB at UCSD. Pokrop also teaches medical-device-courses at UCSD.  He is a contributor and speaker with RAPS and ASQ, both locally and at national meetings.
 
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 and quality since April 2018. She 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, she was an independent regulatory consultant for several years, served as 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 JD from Concord Law School at Purdue University Global. She holds both US and EU RACs.

Kimberly Trautman, MS – Director
Kimberly Trautman is executive vice president medical device international services at NSF International. Previously, she spent 26 years at FDA’s Center for Devices and Radiological Health, including as associate director of international affairs. Trautman has served as chair of the Medical Device Single Audit Program (MDSAP) regulatory council, and as chairperson of the Global Harmonization Taskforce (GHTF) Study Group 3 – Quality Systems. She is a recognized international expert in global medical device regulations, wrote and harmonized the FDA Quality System Regulation 21 CFR § 820 and was on the international authoring group of ISO 13485 since inception. While at FDA, Trautman conceived and developed the MDSAP international consortium of five global regulators, as well as its many foundational documents.