Jim Neher is an accomplished regulatory affairs, clinical research and product development leader with 20 years of life science industry experience encompassing medical devices, in vitro diagnostics, pharmaceuticals and combination products. As Regulatory Affairs & In Vitro Diagnostics Branch Manager, Mr. Neher serves a critical role in ensuring the company’s in vitro diagnostic products meet applicable FDA and international regulatory requirements for quality, safety and effectiveness. This includes guiding device development and lifecycle management, and managing clinical studies, regulatory submissions and international product registration/licensing.
Mr. Neher earned Master of Science and Bachelor of Science degrees in microbiology from Miami University and Indiana University, respectively, and received a Master of Business Administration degree from Bowling Green State University. He has held Regulatory Affairs Certification (RAC) since 2003. His experience includes preparation and management of regulatory filings in the US, Canada, Latin America and Asia Pacific for global manufacturers as well as small companies, and has managed CE Marking activities from labelling to conformity assessment for Class I, IIa, IIb and III medical devices as well as IVD. He has also been responsible for a range of product development and clinical research activities and, in his previous roles in quality and compliance, he developed significant expertise in the areas of complaint management, post-market surveillance, CAPA and continuous improvement/process excellence. Mr. Neher is a member of the Regulatory Affairs Professional Society (RAPS), American Society for Quality (ASQ), Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Associates (SOCRA).