Over the past 20 years James has been exclusively involved in the medical device field focusing on Regulatory Affairs and Quality Assurance. Within this arena he has focused on getting medical devices registered globally. His background and track record demonstrates his leadership, from product concept through obsolescence, by (1.) ensuring regulatory compliance, (2.) providing strategic, tactical and operational direction and support for working within the regulations to expedite the development of safe and effective products, (3.) preparing/submitting submissions and managing communications with the Regulatory Bodies, and (4.) keeping up-to-date with changes to the regulatory environment, science and technology, the medical device industry and the healthcare sector. In 2013 James founded his own company, Monroe Medical Device Consulting LLC, to further to reach a broad range of clients to bring products to market in a more streamlined manner. He currently serves as an Adjunct Professor of RA/QA in the School of Pharmacy at Temple University. In 2020 based on the ever evolving and changing global regulatory requirements he launched a new medical device company, Global RQC Med Device Solutions, whose goal is to provide a global level of expertise to companies seeking global assistance with device registration and regulatory compliance.