Tom Hutchinson

Tom Hutchinson has been an advisor at the NEMIC Foundation since January of 2000. Prior to that, they were the Director of Quality Management Regulatory Affairs at Becton Dickinson from November of 1991 to January of 2000. In that role, Tom was responsible for quality operations across multiple international manufacturing sites, all global regulatory submissions, post-market product quality support, and compliance interface with FDA, EU Notified Bodies, TGA, MHRA, MHLW, ANVISA, etc.

From November of 2010 to March of 2017, Tom was the Vice President of Regulatory Affairs at Davol, Inc. In that role, they assembled a vertically integrated RA team (new product RA strategy, global submissions, change management, clinical trials support) and transitioned leadership to a new leader. Their function objective was to support international growth of business through regulatory submission strategies in current and emerging markets, and the market authorization of novel technologies for patient care. Tom implemented an electronic marketing/sales/labeling review and approval system that became the standard for the entire corporation.

Tom Hutchinson has a MS in Quality Management from the National Graduate School of Quality Management, a BS in Microbiology- Honors from The Ohio State University, and an Executive Development Program from Harvard Business School. Tom is also certified by the Regulatory Affairs Professionals Society (RAPS) in Regulatory Affairs Certification- US, ASQ - World Headquarters in Certified Biomedical Auditor- CBA, and Certified Manager of Quality/Organizational Excellence- CMQ/OE, and Certified Quality Auditor- CQA.