Tom Hutchinson

Extensive global experience since 1991 working in several industries including medical products (pharmaceuticals, devices, and diagnostics) and quality assurance, regulatory and clinical affairs. Has been responsible for multi-site operations, corporate staff functions, global GMP compliance, acquisition evaluation, regulatory submissions (PMA, 510(k), NDA, ANDA, MAA), regulatory influencing functions (FDA, Notified Body, EMA), and clinical program development and management. Solid international reputation in developing and implementing positive quality systems and regulatory strategies while building credibility with regulatory agencies. Tom has managed teams from 5 to 127 professionals, resolved diverse regulatory compliance issues ( 4 pharma FDA Warning Letters, 2 medical device FDA Warning Letters), and managed 100+ regulatory compliance inspections (FDA, ANVISA, KFDA, TGA, 4 different Notified Bodies).