Michael B. Gropp ,
Global Regulatory Strategy
After 3-1/2 years of direct patient care experience, Michael Gropp joined the Medical Devices and Diagnostics Division (MDD) of Eli Lilly and Company in 1980. He held various engineering, regulatory affairs, quality assurance, and compliance positions.
From 1989 to 1995, Mr. Gropp was Director, Regulatory Affairs, MDD Europe, based in London and Brussels. In December 1994, when Guidant Corporation was formed as a separate publicly traded company from the medical device subsidiaries of Lilly, Mr. Gropp joined Guidant. In 1995, he was promoted to Vice President, Quality Assurance, Regulatory Affairs, and Clinical Research for Devices for Vascular Intervention, which became a part of Guidant`s Vascular Intervention Group. Mr. Gropp then served as Guidants Chief Compliance Officer from January 1996 until December 2000, when he took the position of Vice President, Global Regulatory and Public Policy, based in Brussels. As a result of a merger, Mr. Gropp held the same position with Abbott Vascular from April to November 2006.
Mr. Gropp took his current position of Vice President, Global Regulatory Strategy with Medtronic in November 2006 and is based in Minneapolis, USA.
Mr. Gropp is a special representative for international affairs and policy to the Board of Directors of the Advanced Medical Technology Association (AdvaMed)(Washington, D.C.) and Chair of the Eucomed (Brussels) International Affairs Task Force. He is a member of the Global Harmonization Task Force (GHTF) Steering Committee and previously a member of GHTF Study Group 1. He is also an active contributor to the Asia Harmonization Working Party, and a frequent trainer in regional conferences. Mr. Gropp has led efforts to include medical device regulatory harmonisation in the Asia-Pacific Economic Cooperation Life Sciences Innovation Forum and is a member of the advisory board to the APEC Harmonization Center in Seoul. He has served as a member of the Scientific Advisory Group to the World Health Organization's International Clinical Trials Registry Platform project.
On behalf of Eucomed, Mr. Gropp is Co-Chair of the Global Medical Technology Alliance (GMTA), a group of national medical technology associations focused on international policy advocacy.
In October 2010, Mr. Gropp received the Regulatory Affairs Professionals Society (RAPS) Richard E. Greco Award in recognition of his work to help harmonize global medical device regulations and advocate for regulatory professional development. In June 2011, he was asked by the RAPS Board of Directors to chair the newly-formed Global Advisory Council to develop proposals for how RAPS can help develop professional regulatory capacity, especially in less developed economies.
Global Regulatory Strategy