Mary Kay Sobcinski, RN, MHA, has joined RCRI in the role of Senior Principal Advisor, Clinical Sciences. In her 20 years of experience in the medical device industry, Sobcinski has worked for both sponsor and contract research organizations – giving her a unique perspective on the goals and necessities to successfully bring new medical devices, diagnostics and combination products to market.
Sobcinski said, “I am very happy to join the extraordinary consulting experts at RCRI who have tremendous depth of industry knowledge and to add my expertise to partner with medical device innovators.”
Sobcinski’s expertise spans the strategic design and development of innovative and successful clinical trials for medical products including global IDE and IND trial approvals. She also has extensive international regulatory experience involving multiple negotiations with FDA, Health Canada, Notified Bodies, and the Therapeutic Goods Administration (Australia).
“I am so pleased to have an expert of Mary Kay’s caliber joining the RCRI team. Her background in both the CRO and manufacturing settings provides her with a distinct advantage in crafting effective clinical strategies to address the most challenging problems medical device manufacturers face today.” commented Lisa Olson, RCRI President.
Sobcinski’s medical product industry experiences emphasize cardiovascular, neuromodulation, spinal, gastrointestinal, and infectious diseases indications. She combines her extensive medical product experience with healthcare administration and nursing backgrounds to bring a unique approach to corporate, clinical and regulatory strategic planning, marketing, project management and problem solving.
She obtained a Bachelor of Science degree in Nursing from Loyola University Chicago and a Master’s degree in Healthcare Administration from the University of Minnesota.
Contact Mary Kay at firstname.lastname@example.org