Sr. Director, Regulatory Affairs @ (May 2008 - April 2011)
Director, Scientific Affairs @ (March 2006 - May 2008)
Director, Regulatory Affairs @ (December 2003 - March 2006)
Mark O'Donnell Education
University of Michigan 1986-1990
Mark O'Donnell Skills
Medical Devices
Regulatory Affairs
Quality Assurance
GCP
ISO 13485
Product Development
FDA
Biopharmaceuticals
Oncology
Regulatory Submissions
Lifesciences
Design Control
Clinical Development
GMP
CAPA
CMC
Six Sigma
Clinical Trials
Biotechnology
ISO 14971
Quality System
Validation
PMA
Pharmaceutical Industry
Health Economics
Clinical Research
Pharmacovigilance
Cross-functional Team Leadership
Marketing
Leadership
Business Analysis
Process Improvement
Cross Functional Team Leadership
Public Speaking
Regulatory
Microsoft Office
Healthcare
Mark O'Donnell Summary
Mark O'Donnell, based in Westlake Village, CA, US, is currently a Vice President, Regulatory Affairs - Medical Segment at BD. Mark O'Donnell brings experience from previous roles at Medtronic Diabetes, Allergan, Johnson & Johnson and Biosense Webster. Mark O'Donnell holds a 1986 - 1990 University of Michigan. With a robust skill set that includes Medical Devices, Regulatory Affairs, Quality Assurance, GCP, ISO 13485 and more. Mark O'Donnell has 3 emails and 6 mobile phone numbers on RocketReach.
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