Mark R. Willis, LP.D, is widely respected for his expertise in regulatory affairs and strategic consulting within the medical device and healthcare industries. As the founder of a consulting firm established in 2018, Dr. Willis works with leading companies like Medtronic, offering high-level guidance on regulatory, legal, policy, and strategic matters. His work also includes advising the U.S. Food and Drug Administration on issues such as counterfeit pharmaceuticals, blockchain, and training implementation.

In addition to his consulting practice, Dr. Willis has served as a professor at Stonehill University since 2014, where he is dedicated to preparing the next generation of healthcare professionals. He takes great pride in the success of the students he has mentored throughout his academic career.

Dr. Willis holds a bachelor’s degree in economics, a master’s degree in regulatory affairs, and a doctorate in law and policy—all from Northeastern University. He is also actively engaged in global health initiatives through volunteer contributions to the United Nations and the World Health Organization.

His published works include the book Counterfeit Pharmaceuticals: Be Aware of the Danger, which highlights the prevalence and risks of counterfeit drugs—estimated at 30 percent in parts of the world and 10 percent in the United States—as well as numerous peer-reviewed journal articles.

Dr. Willis finds fulfillment in both his professional and personal life. He enjoys spending time with his children and animals and dedicates his work to his wife, Angela Willis, and their seven children. He continues to be driven by the desire to set a meaningful example for his family.

Looking ahead, Dr. Willis remains committed to expanding his work in consulting and teaching, helping shape safer and more effective healthcare systems.