Job title, company, and location:
Professor, Northeastern University, Toronto, Canada
Biography:
Karen Zhou brings over a decade of experience at the intersection of medical device law and regulation, digital health, and AI governance. She has held roles across industry, consulting, and academia, working with early-stage medtech startups through to established multinationals. She brings both hands-on regulatory execution and a broader analytical lens to emerging technology governance, particularly where AI intersects with regulated health products. Her research and writing appear in Therapeutic Innovation & Regulatory Science, Frontiers in Medicine, and RF Quarterly, among others. She has contributed chapters to RAPS and IAPP publications on AI governance in healthcare, co-authored a RAPS book on post-market compliance, and serves on the editorial board of Nature Digital Medicine as well as the Journal of Medical Device Regulation.
Areas of expertise:
Medical device law and regulations, AI governance, regulatory policy
Regulatory jurisdictions covered:
USA, Canada
Education:
B.S, JD, MS, LLM, RAC
Certifications:
Regulatory Affairs Certification (RAC)
Publications (non-exhaustive list):
Book Chapters
- Zhou, K. (2025). Overview of medical device policy and regulation – North America. In Fundamentals of medical device regulation: A global perspective (Chapter 2). Regulatory Affairs Professionals Society.
- Zhou, K. & Gold, K. (2025 or 2026) – AI Governance in Healthcare (under review/recommended for publication)
- AI Governance Professional (AIGP) Handbook – A Publication of the International Association of Privacy Professionals (IAPP)
- Zhou, K. (2022). History of food, drug, and cosmetic laws. In Fundamentals of medical device regulations (Chapter 1). Regulatory Affairs Professionals Society.
- Zhou, K. (2022). Medical device national particularities. In Fundamentals of medical device regulations (Chapter 12). Regulatory Affairs Professionals Society.
- Zhou, K. (2020). Advertising and promotion. In Fundamentals of EU regulatory affairs (9th ed.). Regulatory Affairs Professionals Society.
Book
- Zhou, K. & Gaur, A. (2022). Postmarket requirements for medical devices: A practical guide. Regulatory Affairs Professionals Society.
Articles
- Singh, R., Zhou, K., & Auclair, J. (2025). Reimagining drug regulation in the age of AI: A framework for the AI-enabled ecosystem for therapeutics. Frontiers in Medicine – Regulatory Science, Volume 12 – 2025 https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1679611/full
- Zhou, K., & Gattinger, G. (2024, November). Canadian regulatory framework for software-based medical devices and emerging technologies. Journal of Medical Device Regulation.
- Zhou, K. (2024). The role of data in AI governance in healthcare: A cross-jurisdictional analysis. RF Quarterly, 4(3), 43–53.
- Zhou, K., & Gattinger, G. (2024). The evolving regulatory paradigm of AI in MedTech: A review of perspectives and where we are today. Therapeutic Innovation and Regulatory Science, 58, 456–464. https://doi.org/10.1007/s43441-024-00628-3
- Zhou, K. (2023). The evolution of Canada’s medical device regulatory framework. RF Quarterly, 3(2), 22–30.
Professional link:
LinkedIn: https://www.linkedin.com/in/karen-zhou-rac-892221a3/
