Lacey Harbour Smith
Vice President, Quality and Regulatory Advancement
LinkedIn: I hope you will connect with me via LinkedIn: Connect with Lacey
Email: Feel free to reach out with any questions or ideas you have: Lacey.Harbour@Pathway4PH.org
Lacey Harbour Smith brings to Pathway for Patient Health extensive leadership experience in regulatory affairs, quality systems, artificial intelligence, cybersecurity, and emerging technology governance. She is recognized for advancing collaborative approaches that enable innovative healthcare technologies to be developed, deployed, and governed safely.
Prior to joining Pathway, Harbour Smith served as Senior Regulatory Affairs Manager for Emerging Technologies and Cybersecurity at Thermo Fisher Scientific, where she led enterprise-wide regulatory strategy for AI, cybersecurity, and digital health across global product portfolios. She also served as a corporate liaison to FDA and international regulatory bodies and developed an AI-powered regulatory operations platform that transformed global regulatory intelligence into actionable guidance. Previously, she directed U.S. Regulatory Affairs and Quality Systems at Lima Corporate, where she established the first FDA-registered in-hospital 3D printing point-of-care manufacturing facility. She also founded Harbour Regs LLC, providing regulatory and compliance consulting to medical technology organizations.
A frequent speaker and policy advisor, Harbour Smith is recognized for her work in AI governance, Good Machine Learning Practice (GMLP), Software as a Medical Device (SaMD), laboratory-developed tests (LDTs), and cybersecurity. She serves as Co-Leader of the Healthcare and Public Health Sector Coordinating Council (HSCC) AI Secure by Design Working Group and as the RAQA Lead (previously AI Advisor) to the Biohacking Village.
At Pathway, Harbour Smith leads Working Groups within the Pathway Collaborative Community Centers, advancing initiatives chartered by the Chief Quality Officer Team and overseen by the Collaborative Community Steering Committee.
She holds an M.S. degree and Regulatory Affairs Certified (RAC) and Medical Laboratory Scientist (MB, ASCP) professional credentials.