Celebrating Regulatory Trailblazers

Over her 30 years as a RAPS member, Linda has served the regulatory profession on countless committees, and as a RAPS Board member, author, chapter leader, presenter, mentor, and more. She is the editor of the newly released Regulatory Intelligence, Reimagined, and currently serves on the RAPS Institute Board.

For over 30 years, Kevin has served as a quality systems instructor, mentor, and teacher for the regulatory and quality community. He has been a prolific contributor to Regulatory Exchange, RAPS’ online member community, where his comments have helped countless professionals navigate the complicated scenarios innate to a career in regulatory and quality. He holds the RAC-US, RAC-EU, RAC-Canada, and RCC-MDR credentials.

Since she started her career in regulatory and quality in 2018, Katelin has overseen regulatory submissions and approvals while leading teams in both medical devices and pharmaceuticals. Katelin contributed to Fundamentals of Medical Device Regulations: A Global Perspective and helped create the RAPS Greater Cincinnati Local Networking group in 2025. She holds the RAC-Device and RCC-MDR credentials.

Over three decades of experience in regulatory compliance, Ludger has founded multiple organizations dedicated to supporting medical device companies throughout the complex regulatory process. He has participated as a member of the European Union’s Medical Device Coordination Group, is a founding member of the RAPS Germany Chapter, and has been a regular speaker at international conferences and panels.

Chris Whalley is shepherding the future of regulatory affairs as RAPS Convergence Planning Committee Chair and contributing to books like Regulatory Intelligence Reimagined. Chris has also served on the RAPS Convergence Planning Committee as a member and as vice chair, and currently leads regulatory intelligence activities at Pfizer as their senior director and head of global regulatory intelligence & analysis.

For more than 40 years, Alberto Grignolo has contributed his expertise as a regulatory and drug development professional and corporate executive, including 32 years as a consultant to pharmaceutical and biotechnology companies and driver of a successful worldwide regulatory and drug development consulting business.

For years, Victor Mencarelli has shared his experience as one of our top contributors on Regulatory Exchange (RegEx), the RAPS online member community, where he contributes to discussions that help regulatory affairs professionals learn from his time as a director of global regulatory affairs.

As director of global postmarket surveillance at Smith + Nephew, chair of MedTech Europe’s PS and Vigilance Working Group, and as a member of the EU Medical Device Coordination Group’s Task Forces for Vigilance, PSUR, and postmarket surveillance, Markus Pöttker has navigated complex regulatory realities and advanced the field of postmarket surveillance.

Paul Brooks has served the regulatory affairs profession in a way few others have. After more than 20 years at BSI and serving as chair of the RAPS Board of Directors, Paul became the executive director at RAPS in 2016. As our society’s leader, he took RAPS to new heights as we grew our membership to new levels, expanded our global reach, and refined and improved many key initiatives before his retirement in 2020.

Susan Stewart has shaped regulatory strategy and contributed to innovation across multiple organizations as a leader in regulatory affairs. Susan first worked her way up from associate to vice president of regulatory affairs at Genzyme Corporation, and has worked in leadership roles at Transmolecular, Tokai Pharmaceuticals, Kaleido Biosciences, Frequency Therapeutics, Q23 BIO, Candel Therapeutics, and Rezolute Bio.

Susan has served the profession as a member of the RAPS Board of Directors, the RAPS Fellows Committee, the Rare Disease Company Coalition Board of Directors, and as regulatory advisor to the Termeer Foundation. She has earned her RAC-US and RAC-EU credentials.

Angelina Lisandrelli has served the regulatory affairs profession as an accomplished medical device expert, volunteer, and mentor. During a 15+ year career that began in chemistry, Angelina has developed regulatory strategies, led teams, and built relationships across industry, health authorities, and notified bodies. She is a member of the RAPS Convergence Planning Committee, RAPS Membership Committee, and RAPS Education Committee, and has mentored countless professionals through the RAPS Mentoring Program.

Over more than 20 years in regulatory affairs, Kate Stockman shaped today’s regulatory environment by developing creative strategies, successfully engaging with health authorities, and delivering global product approvals across many product categories. Kate has served as the co-chair of the RAPS Euro Convergence Planning Committee for the past two years and is a member of the RAPS European Council.

In addition to her regulatory roles with Boehringer Ingelheim, Merck Serono, Wyeth Australia, Genzyme Australasia, Medicines Australia, and as a consultant, Orin has helped prepare the next generation of Australia’s healthcare professionals as a professor and program director at the University of Sydney and University of New South Wales. She is a member of the RAPS Editorial Advisory Committee and a RAPS Fellow.

Richard Vincins rose to his position as director of regulatory and quality at MD Compliance after a career compiling regulatory submissions, driving regulatory strategy for new and novel products, performing quality system assessments, and supporting audits/inspections of quality systems. He has managed teams, mentored regulatory professionals, presented at conferences, and more. Richard is RAPS’ all-time leader in discussion posts in Regulatory Exchange, our online community, where he continues to provide regulatory professionals with advice on a daily basis.

Mark Kramer helped establish FDA’s Office of Combination Products and served as its first-ever director upon the office’s inception in 2002. After spending 17 years over two stints at FDA, Mark transitioned to industry and served as a regulatory leader at GE, Greenleaf Health, and Eliquent. Mark has taught as an adjunct professor in St. Cloud State’s regulatory affairs master’s program and has served on the RAPS board of directors. He now serves as an independent consultant and holds the RAC-US credential.

Salma Michor has served as a RAPS volunteer for 20 years, giving back as a RAPS board member and treasurer, books volunteer, and most recently as a founding member and the chair of the RAPS EU Board of Directors. Salma held the role of CEO & Principal Consultant for Michor Consulting and Trade Services for 15 years, and has supported regulatory functions for Pfizer, Karmed, QbD Group, and other organziations. She is currently chief regulatory and commercial officer at PowerVet. She holds the RAC-Global and RAC-EU credentials. 

Lena Cordie-Bancroft served the regulatory profession across two continents a volunteer during her time in Minnesota, where she chaired the RAPS Twin Cities Chapter, and in England, where she served on the RAPS European Council (REC) and was a leader for the RAPS UK Local Networking Group. Lena was owner and principal consultant at Qualitas Professional Services before joining BSI as sector lead – healthcare in 2021. She is currently a global standards advisor at Medtronic. 

Michelle Ragozzino served the regulatory affairs profession as a longtime leader of the RAPS San Francisco Chapter. After serving as the program director for biosciences at UC Santa Cruz Extension, Michelle moved to industry. Across Abbott Vascular, Cordis, and NeuroPace, where she currently works as director of regulatory affairs, Michelle has worked to help Class II and III cardiovascular and endovascular devices and a Class III active implantable neuromodulation device get to market. She was one of three recipients of the inaugural RAPS Community Leadership Award in 20217 and holds the RAC-Devices credential.

As a longtime independent consultant, Arvilla Trag has specialized in CMC compliance and regulatory affairs for more than 30 years. As a volunteer, she has RAPS workshops, presented at conferences, and has been a vital contributor to Regulatory Exchange, the RAPS online member community. She holds the RAC-US credential.

In over 40 years in the medical device industry in roles across academic, consulting, and health authority settings, Arthur Brandwood has provided expertise to the global medtech community in many forms. He currently serves as president of Lifesciences Australia and is a visiting professor at the University of Sydney after tenures at the University of New South Wales, Australia's Therapeutic Goods Administration, his own Brandwood CKC, and many other roles.

Over 30 years working for healthcare companies and academic institutions, Grace Gowda’s career has spanned basic research to clinical research, bench work to registration of new products. Grace spent 16 years at Merial Limited before moving first to Boehringer Ingelheim and finally to the University of Georgia, where she is the director of its International Biomedical Regulatory Sciences Program and a professor at the UGA College of Pharmacy. She is a RAPS Fellow.

Gert Bos has served the regulatory affairs profession as a volunteer and as an expert in European regulations, with 25 years as an auditor, product reviewer, regulatory specialist, head of notified body, and consultant. He is a former chair of the RAPS Board of Directors, a founding member of the RAPS EU Board, a board member and founding member of the RAPS Netherlands Chapter, a presenter and committee member at RAPS conferences, a workshop leader on medical devices, and an author, including as a lead editor of Software as a Medical Device. Gert worked as a certification manager and technology manager at DEKRA before spending six years at BSI, first as head of regulatory and clinical affairs, and later as head of Notified Body 0535. He is currently a partner and chief scientific officer at QServe Group. Gert is a RAPS Fellow and a recipient of the RAPS Founder’s Award. He has also served as president of TEAM-NB, the European association of notified bodies.

Jay Vaishnav has served the regulatory affairs profession as an author, editor, educator. She spent seven years at FDA, first as a physicist in the Center for Devices and Radiological Health (CDRH), and then as acting associate director for CDRH’s Office of Science and Engineering Laboratories. As director of regulatory affairs at Canon Medical Informatics, Jay is the US regulatory lead for an advanced imaging software portfolio that includes AI/ML SaMD, cardiac imaging, and structural heart planning applications. Jay is an advisory board member and instructor UC Santa Cruz Silicon Valley Extension. She is also a lead editor of Fundamentals of Medical Device Regulations: A Global Perspective and From X-Rays to AI: Navigating US Regulations in Radiological Health. Jay is a RAPS Fellow, and she holds the RAC-Devices credential.