Mary Kay Kessinger Sobcinski, RN, BSN, MHA, is a Senior Consultant to medical device companies around the world.
She has extensive experience in clinical trial strategy development, design and management; data management; medical product education; medical product marketing; and education and mentorship.
She has held senior management roles in both clinical and regulatory affairs for medical devices, biologic drugs, and combination devices. She has authored numerous successful worldwide regulatory submissions for clinical trial and product approvals.
Mary Kay has more than 20 years of industry experience with an emphasis on cardiovascular, neuromodulation, spinal, gastrointestinal and infectious diseases indications as well as nursing and hospital administration experience. She has been a member of numerous multidisciplinary product development teams and has led many teams to successful project completion.
She is a highly regarded speaker and educator. Her extensive medical product experience, nursing expertise and administrator background enable her to bring a unique perspective to strategic planning, project management, team development, problem solving and interdisciplinary communication. She has been a member of the St. Cloud State University Applied Clinical Research program faculty since its inception in 2010.