Richard is responsible for ensuring global regulatory compliance for Inspirata’s solution offerings. He has more than 20 years of experience in manufacturing operations, international regulatory affairs, quality systems, risk management, clinical development and regulatory compliance within the aerospace and medical device industry.
He previously was Director of Quality and Regulatory Affairs at VuCOMP, where he designed, implemented and maintained an FDA/ISO-compliant quality system, achieved USFDA premarket approvals/premarket notifications and various international market clearances. He also designed and executed clinical studies and had overall responsibility for global regulatory compliance.
Prior to VuCOMP, Richard was Vice President of Global Market Clearance Solutions. His casework included global market clearance strategy, international product registrations, quality systems development and implementation, and risk management planning and integration for medtech industry clients. He successfully executed challenging market clearances in Brazil, Mexico, South Korea, China, Japan, Taiwan, Singapore, Australia, Canada and the U.S.
He holds a Regulatory Affairs Certification in Medical Products from the Regulatory Affairs Professional Society, and a Quality Auditing Certification from the American Society for Quality.
Richard served as Chairman of the Membership Committee for the Regulatory Affairs Professional Society and Chairman of the STED Working Group, which comprised numerous representatives from industry, international regulatory authorities and standards organizations. He also was a member of the Board of Editors for the Regulatory Focus publication, and is a contributing author of Fundamentals of U.S. Regulatory Affairs, the medtech industry’s definitive reference. He was certified by the Regulatory Affairs Professional Society as an Educational Service Provider, and he has delivered Certified Professional Education in global regulatory affairs and quality to thousands of industry professionals worldwide. Richard graduated from Chapman University with a Bachelor’s degree in Electronics.