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Celebrating Regulatory Trailblazers

In 2026, we’re celebrating 50 years of regulatory affairs by recognizing 50 outstanding regulatory professionals.

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This Week's Recognition: Chris Whalley

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.

Fifty for 50 Recognitions

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Peter Barton Hutt

As FDA’s chief counsel from 1971-1975, Peter overturned the agency’s long-held view that it had no authority to issue binding, substantive regulations. Using this newfound rulemaking authority, Peter created the FDA Regulatory Letter (now the Warning Letter), nutrition labeling requirements, Freedom of Information Act regulations, and other elements core to the regulatory profession today.
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Kamana Singh

Kamana Singh has spent almost two decades building regulatory systems that protect patients, empower teams, and support the development of innovative therapies. Across her career, she has led complex global labeling programs and supported organizations through pivotal regulatory milestones. As a speaker, mentor, author, and RAPS chapter leader, she has advanced the regulatory profession and supported regulatory affairs professionals as they navigate their way through the profession.
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Frederike Brühschwein Mandic

Frederike has spent more than 15 years in the medical device field developing and executing global regulatory strategies, leading and mentoring multi-disciplinary teams, and consulting for startups and established global corporations. She is a member of the RAPS Euro Convergence Planning Committee and has her RAC-Devices credential.
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Janet Michener Whipple

Over 35 years working in the regulation of medical devices, IVDs, and combination products, Janet Michener Whipple has overseen large regulatory and quality projects for medical device and IVD firms, led activities to remediate design controls, CAPA and MDR reporting processes after receipt of FDA Warning Letters and untitled letters, and more. Janet was the founding chair of the RAPS Southern California Local Networking Group and has her RCC-IVDR credential.
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Heena Thakkar

Heena Thakkar has spent her young regulatory career as a passionate promoter for upskilling and mentorship in regulatory affairs, first in roles at medical device companies in the US and India and now as an independent consultant. She holds her RCC-MDR credential and is a regular contributor on Regulatory Exchange (RegEx), the RAPS online member community.
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Silu Zhang

Silu Zhang is a global regulatory leader who has shaped regulation through standards development and sustained engagement across regulators, industry, and academia. Her work has strengthened regulatory science and helped build more efficient, internationally aligned regulatory frameworks, including by participating in regulatory revisions that removed after-sales service organization requirements from NMPA registration certificates in China. She is a member of the RCC-IVDR Committee and holds the RAC-Devices, RCC-MDR , and RCC-IVDR credentials.
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James Wabby

James is the chair of the RAPS Southern California Local Networking Group and is an alum of the RAPS Kellogg Executive Development Program. Over more than 25 years in regulatory and quality, James has driven regulatory innovation across combination products, medical devices, digital medicine, and complex generics. James has contributed to RAPS Fundamentals of Medical Device Regulations: A Global Perspective and has been a speaker at RAPS Convergence, the RAPS Global Regulatory Strategy Conference, and other regulatory and quality events.
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Linda Bowen

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.

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Kevin Randall

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.

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Katelin Henninger

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.

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Ludger Moeller

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.

Help us celebrate 50 regulatory trailblazers!

For RAPS' 50th Anniversary, we're shining a spotlight on 50 outstanding regulatory professionals who have contributed broadly in the field. Each selected honoree will be featured in RAPS communication throughout the year. All submissions are reviewed by the Nominating Committee.

Shaping Regulatory Excellence and Innovation since 1976

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