Regulatory Affairs Expert Witnesses in Kentucky

This qualified expert received his BA from Valparaiso University and is a licensed OSHA trainer for numerous courses. He has managed various construction safety projects including the installation and modification of industrial equipment valued at over a billion dollars. Formerly, he served as a night safety manager for Gallagher Kaiser at General Motors and as a safety manager for NKC American at Toyota Motor Manufacturing. He currently is the safety manager for a prominent aluminum manufacturer overseeing the installation of a new stamping bed.

This highly qualified expert has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has 18 years of industry experience as a mid-level Manager and Senior Executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions, and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. Currently, he is an Industry Consultant with a leading FDA consulting corporation.