Mark Mortellaro

Mark Mortellaro, PhD, RAC-Devices has extensive work experience in the regulatory field, specifically with Class III diagnostic medical devices. Mark has worked at Senseonics, Incorporated since 2002 and currently holds the position of Sr. Principal Regulatory Scientist. In this role, they lead and supports submissions to US and EU regulatory agencies and provides regulatory strategy advice and product development support. Mark is also responsible for regulatory intelligence and ensuring company compliance to regulations and laws. Notably, they authored sections of the original PMA submission for FDA approval. Throughout their tenure at Senseonics, they have held various roles including Director of Chemistry, R&D, Manager of Chemistry R&D, Group Leader of Chemistry, and Scientist. In these positions, they played a key role in preparing regulatory submissions and resolving obstacles for CE Marking and PMA approval.

Mark Mortellaro, PhD, RAC-Devices holds a Ph.D. in Organic Chemistry from The Ohio State University and a Bachelor of Science (B.S.) in Chemistry from Youngstown State University. In addition to their formal education, they have obtained various certifications, including RAC-DEVICES from the Regulatory Affairs Certification Program and several project management certifications from LinkedIn. Mark is also a member of the Regulatory Affairs Certification Program and the Regulatory Affairs Professionals Society (RAPS). In 2023, they plan to obtain a certification in "Understanding How Medical Devices are Regulated in Canada" from Health Canada | Santé Canada.