Vice President, Regulatory Affairs @ From May 2011 to Present (4 years 8 months) Sr. Director, Regulatory Affairs @ Responsible for global regulatory affairs functions for Medical Device division of Allergan. From May 2008 to April 2011 (3 years) Director, Scientific Affairs @ Responsible for all activitities for Regulatory Affairs, Quality Assurance, and Health Economics in the EMEA region From March 2006 to May 2008 (2 years 3 months) Director, Regulatory Affairs @ Responsible for new product registration, advising product development teams, maintaining relationships with FDA, BSI, other regulatory agencies From December 2003 to March 2006 (2 years 4 months)

University of Michigan From 1986 to 1990 Mark O'Donnell is skilled in: Medical Devices, Regulatory Affairs, Quality Assurance, GCP, ISO 13485, Product Development, FDA, Biopharmaceuticals, Oncology, Regulatory Submissions, Lifesciences, Design Control, Clinical Development, GMP, CAPA