Rogelio C. Rodriguez
COO, Regulatory Affairs and Quality Assurance
Rogelio C. Rodriguez is a scientific consultant to the regulated medical device industry. He supports clients with FDA 510(k) submissions, CE Mark submissions (MDR 2017/745), and quality management systems (ISO 13485, FDA QSR). His expertise revolves around engineering, science, and medical device compliance management, which involves conducting assessments for product approval and post-market activities.
Rogelio’s professional experience includes systems engineering, higher education management, corporate training, teaching, and consulting. As Director of Engineering, Science, and Life Science programs at the University of California, School of Continuing Education, Rogelio established the Medical Product Development, Clinical Trials, and Medical Device Engineering certificate programs.
Rogelio holds a B.S. in Electrical and Computer Engineering from California State University Fullerton, an M.S. in Electrical and Computer Engineering from California State University Long Beach with an emphasis in biomedical engineering, as well as a Certificate in Management Practices for Technical Professionals from the University of California Irvine and registered with the California Board of Registration for Professional Engineers.