Jorge A. Castaños

Jorge A. Castaños has over 20 years of work experience in quality assurance and regulatory affairs. Their most recent role was as Vice President of Quality Assurance and Regulatory Affairs at Integer Holdings Corporation. Prior to that, they served as Vice President of Quality Systems & Regulatory Affairs at Ohmx Corporation from 2015 to 2019, where they were responsible for bringing an innovative IVD device to market. Jorge A. also held the position of Vice President of Global Quality Systems & Regulatory Affairs at Ohio Medical Corporation from 2010 to 2015, where they served as the principal liaison with regulatory agencies and notified bodies. Before that, they worked as Vice President of Global Quality Systems at Smiths Medical and as Global Director of Regulatory Affairs & Quality Assurance at Teleflex Medical. Jorge A. began their career at Abbott Laboratories, where they focused on global pharmaceutical compliance assurance. Jorge A. also served as Director of Quality Assurance International at Monsanto. Overall, Jorge A. Castaños has a strong background in quality and regulatory affairs in the medical and pharmaceutical industries.

Jorge A. Castaños has a Master of Business Administration (MBA) degree with a focus on Marketing and Finance from Northwestern University - Kellogg School of Management. Jorge A. also holds a Bachelor of Arts (B.A.) degree in Chemistry from Knox College. Additionally, they have a Master of Science (M.S.) degree in Pharmaceutical QA/RA from Temple University, School of Pharmacy. Castaños has obtained certifications including ISO 13485:2016 Lead Auditor from the British Standards Institute (BSI), Aseptic Drug Processing from the PDA - Parenteral Drug Association, ICH Q7a on Active Pharmaceutical Ingredients, ISO 9001 Lead Assessor from Lloyd's Register Quality Assurance (LRQA), and Microbiology and Engineering of Sterilization Processes from the University of Minnesota.