Sally Maher

Sally L. Maher is a seasoned regulatory, clinical affairs, and health care compliance strategist with more than 25 years of experience guiding complex medical devices and combination products from development through regulatory clearance and commercial access. She leads regulatory strategy and clinical integration at Cambridge Orthopaedic Labs and serves as principal of S Maher Consulting, providing expert advisory in regulatory submissions, quality systems, reimbursement strategy, and compliance across the medtech ecosystem. 

Ms Maher’s previous executive roles include vice president of Regulatory & Clinical Affairs at Edwards Lifesciences and senior leadership in regulatory, reimbursement, and health care economics at Smith & Nephew’s Advanced Surgical Products Division. Her career spans foundational work at the U.S. Food and Drug Administration and senior regulatory posts at Johnson & Johnson, Pfizer, and early-stage wound-care and device firms, giving her a unique perspective on evidence requirements, regulatory pathways, and market access dynamics. 

She holds a Juris Doctor degree from the University of Baltimore, a bachelor’s degree from Ohio Wesleyan University, and the Regulatory Affairs Certification (RAC). Ms Maher also contributes to industry education as an adjunct professor and engages in cross-stakeholder efforts to improve regulatory and clinical frameworks that support innovation and safe patient access to advanced therapies.