Dr. Mark R. Willis, LP.D is a globally recognized expert in regulatory affairs, legal strategy, and policy consulting for the medical device and pharmaceutical industries. Since launching his consulting company in 2018, Dr. Willis has provided strategic guidance to major corporations such as Medtronic, while also advising agencies like the FDA on issues ranging from counterfeit pharmaceuticals to the use of blockchain technologies in healthcare regulation.
He holds a B.A. in Economics, a Master’s in Regulatory Affairs, and a Doctorate in Law and Policy, all from Northeastern University. As a longtime professor at Stonehill University, Dr. Willis finds deep fulfillment in mentoring the next generation of healthcare leaders. His academic and professional work includes the publication of the book Counterfeit Pharmaceuticals: Be Aware of the Danger—a vital resource on the risks posed by fake drugs, especially in underserved regions.
With a passion for public service, Dr. Willis also volunteers with the United Nations and World Health Organization, further cementing his role as a thought leader in global health policy. He finds personal joy in spending time with his wife Angela and their seven children, often surrounded by family and animals.
His guiding philosophy—driven by love, coffee, and a desire to lead by example—is to inspire his children through continuous learning and purposeful work in teaching and consulting.