My Profile

Michael Sharp, FRAPS, PhD

Contact Details

United States

Bio

Senior Regulatory Affairs and Clinical Research and Quality Executive with more than 30 years of experience in the medical device and pharmaceutical industry and academics. Responsible for the development and prosecution of more than 50 510(k)s, 5 PMAs and 2 NDAs as well as numerous IND, IDE and CE Mark Technical Dossier submissions and international registrations for products in the ophthalmic, orthopedic and cardiovascular areas
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Education

California Coast University
PhD
1992 To 1996

Dartmouth College - The Tuck School of Business at Dartmouth
Diploma
1988 To 1988

The University of North Dakota
MA
1970 To 1971

Chapman University
BA
1967 To 1970

Job History

Editor in Chief
September 2015 - present

Editorial Board Member
October 2014 - present

Founder and Principal Consultant
January 2012 - present

Senior Consultant
January 2012 - present

Corp. VP Regulatory and Medical Affairs
December 2008 - November 2011

Faculty (P-T), Clinical Research Program
January 2007 - January 2011

Sr. Vice President, Regulatory and Clinical Affairs
June 2006 - December 2008

VP Regulatory, Quality and Clinical
January 2005 - June 2006

Assistant Professor of Oncology and Hematology
January 2003 - December 2004

Director of Clinical Research and Chief Regulatory Officer
January 2003 - December 2004

Clinical Director of Regulatory Affairs
August 2001 - January 2003

Group Manager, RA
January 1999 - January 2001

Vice President, Regulatory and Clinical Affairs
January 1993 - May 1999

Vice President, Regulatory and Clinical
January 1989 - January 1993

Manager, Regulatory Affairs
October 1986 - October 1989

Education

  • Doctorate degree (PhD, ScD, MD, DVM, DMD, PharmD or other clinical doctorate, etc.)

Regional Areas of interest

  • Global