J. Lawrence Stevens

J. Lawrence Stevens, R.A.C. is a FDA and private industry experienced expert based at Greater St. Louis Area. He has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He was responsible for designing quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. He completed his Bachelors in Biological Sciences from California State University, Fullerton. He also completed a one year program of M.B.A. at Golden Gate University, Santa Barbara, CA. He is Certified in Regulatory Affairs (RAC) by the Regulatory Affairs Professionals Society in the year 1991. He serves as a Member, Board of Directors, National Alliance on Medical Illness, Southern Illinois Division, a non-profit organization offering assistance to persons or families dealing with mental illness, and advocating on their behalf since August 2011. He is a member of Regulatory Affairs Professionals Society, American Society for Quality and FDA Alumni Association. At present he is the Principal Consultant at One Way Consultants, LLC, FDA Regulatory Experts and a professional public speaker who can train persons on all aspects of FDA requirements, and practical and successful solutions to FDA problems. He has published articles in peer journals on managing clinical trials, and design control for medical devices. He was the recipient of FDA Commendable Service Award and FDA Special Achievement Award, FDA Office of Criminal Investigations.