Jake O’Donnell, R&Q’s Senior FDA Compliance Principal, is a former FDA Consumer Safety Officer and Medical Device Specialist. Jakes has over 20 years of experience at the FDA where he conducted hundreds of medical device inspections for the FDA, as well as investigations of regulated products at user facilities. He will discuss how problems arise with FDA audits, common challenges related to specific points in the business cycle, audit management tips, best practices for responses, and more.
Julie Maes is R&Q's brand new Director of Territory Operations - Northern Lakes Region. An industry veteran of the global healthcare and medical device industry, Maes brings extensive management and hands-on quality systems development experience to R&Q’s expanding Minnesota area operations. In her role at R&Q, Maes will manage designated resources to guarantee the highest quality consulting and complete customer satisfaction in the region. She will also contribute to R&Q’s Center of Excellence as a subject matter expert, providing industry education on the most critical and timely regulatory and quality challenges facing our market.
More About Jake O'Donnell
Jake O’Donnell has a diverse professional background that includes over 20 years of experience as an FDA Consumer Safety Officer and Medical Device Specialist, as well as 10 years with the U.S. Navy working as an Aerospace Engineer and Program Manager. During his time with the FDA, he gained valuable insight into the medical device world by conducting hundreds of FDA inspections – including those that are routine, compliance, PMA and directed EIs – of medical devices, as well as investigations of regulated products at user facilities. Additionally, he has completed over 50 international inspections on multiple continents, including Asia. Throughout the years, Jake has developed extensive knowledge of the guidelines and regulations associated with internal audits as a result of his development and delivery of training materials to qualified FDA auditors. With his bachelor’s degree in mechanical engineering from Penn State combined with diverse industry experience, Jake brings an unmatched, immense product understanding and ability to apply specific device regulations that may otherwise be overlooked. Thanks to his broad experience base, he is able to execute a balanced approach to QMS, regulatory, and technical issues, all while applying expert knowledge of the FDA’s QMS expectations, guidelines, and internal review mechanisms to all of his engagements.
