These 6 regulatory professionals are the 2024 RAPS Fellows
RAPS has named six regulatory professionals to the distinguished ranks of the RAPS Fellows Program.
Every year, the RAPS Fellows Program bestows honorary recognition upon exceptional leaders making noteworthy and sustained leadership contributions to their organizations, RAPS and the regulatory profession.
Fellows receive a dignified status and hold the FRAPS designation. They serve as important advisors and mentors for strategic collaboration, implementation of special initiatives, and international development across the regulatory community.
The 2024 RAPS Fellows are:
Sabine Haubenreisser, MSc, PhD, FRAPS, Principal Scientific Administrator at the European Medicines Agency
Sabine is a pharmacologist with a special interest in regulatory and scientific cooperation to the benefit of public health through engagement with external stakeholders. She has held various positions at the European Medicines Agency (EMA) and has served as EMA Liaison Official at the US Food and Drug Administration (FDA), where she strengthened cooperation between the European Regulatory Network and the FDA. During this time, she oversaw completion of the EU/US Mutual Recognition Agreement on GMP inspections and development of new platforms for cooperation on patient engagement and rare diseases.
Megha D. Iyer, MSc, MS, RAC, FRAPS, Director of Global Strategic Regulatory Affairs at Thermo Fisher Scientific
Megha has led global teams with a wide range of portfolios and collaborated with regulatory authorities to guide the development of new policies and regulations. As director of global strategic regulatory affairs at Thermo Fisher Scientific, she shapes regulatory intelligence, policy, and advocacy across the organization's diverse businesses. She occupies leadership positions in industry associations like MedTech Europe and the Association for British Healthcare Industry (ABHI). Megha currently serves as chair of the RAPS Convergence Planning Committee.
Allison Komiyama, PhD, RAC-US, FRAPS, Vice President, MedTech Innovations at RQM+
Allison has been actively involved in hundreds of pre-submissions and premarket submissions for a wide array of medical device companies. She founded her own company, AcKnowledge Regulatory Strategies, in 2014, and it was purchased by RQM+ in 2021. At RQM+, she and her team continue to work with small to large medical device companies as they now support all device types during the entire product lifecycle. Much of her recent work has been focused on digital therapeutics, monitoring devices, smart orthopedic devices, wearable technology, pediatric devices, and neurostimulators with unique indications. She frequently presents at conferences, is an advisor at numerous technology incubators, and teaches students around the world about regulatory submissions as a faculty member at the UC San Diego Division of Extended Studies extension and SDSU Global Campus.
Sequita Lindsey, MSRA, RAC-Global, FRAPS, President and CEO of Lindsey Regulatory Affairs Consulting
At Lindsey Regulatory Affairs Consulting, Sequita provides strategic and operational guidance to medical device companies in several global markets. With more than 17 years of regulatory affairs experience in the biomedical and medical device industry, she has a track record of successfully managing complex projects and submissions across various regulatory jurisdictions and product categories. Her core competencies include developing and directing regulatory strategies for earliest possible approvals, translating regulatory requirements into practical and workable plans, ensuring compliance with global regulatory standards and best practices, and leading and managing regulatory teams and resources.
Mindy McCann, MS, FRAPS, Principal Consultant at QServe Group
Mindy has over 30 years of multi-faceted, hands-on medical device regulatory and industry experience. She has diverse experiences as a consultant, executive, development engineer, notified body auditor, and technical and clinical documentation/submission author and reviewer. This serves as the foundation to support her track record in providing practical approaches in developing and implementing regulatory, quality and clinical strategies, including supporting documentation. Mindy enjoys sharing her passion for the regulatory profession through continuous education, training, and engaging debate.
Jay Vaishnav, PhD, RAC-Devices, FRAPS, Director, Regulatory Affairs at Canon Medical Informatics
Over her 20-year career, Jay has helped commercialize hundreds of medical imaging and radiation therapy software and hardware devices. She has led regulatory efforts at both multinational corporations and startups, following a decade of federal service at the FDA and the National Institute of Standards and Technology. Jay has also been both a university instructor of regulatory affairs and a professor of physics. She is the co-editor of the forthcoming Fundamentals of Medical Device Regulations: A Global Perspective and From X Rays to AI: Navigating US Regulations in Radiological Health, and she has contributed to the development of the RAC-Devices exam.
To become a RAPS Fellow, one must be a proven leader who has demonstrated distinct dedication to the regulatory profession with a history of commitment and success. Professionals who are selected to the program receive the FRAPS designation and are acknowledged during RAPS Convergence, the largest annual conference dedicated to healthcare product regulation and regulatory issues. This year's event occurs 17-19 September in Long Beach, California.
“The honor of being named a RAPS Fellow is reserved for those outstanding regulatory leaders who not only excel in the field, but who also go above and beyond to give back to the profession, their peers, and future generations of regulatory professionals,” said RAPS Executive Director Bill McMoil. “RAPS and the global regulatory community are enriched by the involvement of these distinguished leaders and advocates.”
More information about the Fellows program, including previous classes, application process and selection criteria information and more, can be found here.