Regulatory Affairs Specialist @ (May 2021 - June 2024)
Regulatory Affairs Manager @ (March 2020 - May 2021)
Global Regulatory Affairs Management Medical Devices @ Seeking a New Opportunity (February 2020 - March 2020)
Regulatory Affairs Manager @ (January 2019 - February 2020)
Principal and Owner @ ORGENIX, LLC (March 2007 - December 2018)
Principal @ ORCA, LLC (November 2004 - May 2006)
Vice President and Founder @ MCRA, LLC (January 2001 - January 2004)
Group Leader and Sr. CRA @ IOLAB (January 1983 - January 1990)
Don Guthner Education
The Julius Maximilians University of Würzburg
none (Human Medicine)
1972-1976
Oregon State University
BS in General Science (pre-med) (Health Services/Allied Health/Health Sciences, General)
1970-1972
Don Guthner Skills
Product Registration
PMAs
Regulatory Strategy
Project Management
MDSAP
Good Manufacturing Practice (GMP)
Cross-functional Team Leadership
Regulatory Filings
International Regulations
Regulatory Documentation
Regulatory Requirements
Problem Solving
Premarket Approval (PMA)
Organization Skills
Market Assessments
Communication
Documentation
Clinical Development
Electronic Data Capture (EDC)
Medical Research
Don Guthner Summary
Don Guthner, based in Douglassville, PA, US, is currently a Regulatory Affairs Consultant at Maxx Orthopedics Inc.. Don Guthner brings experience from previous roles at Kapstone Medical, Camber Spine, Seeking a New Opportunity and Neuronetics, Inc.. Don Guthner holds a 1972 - 1976 none in Human Medicine @ The Julius Maximilians University of Würzburg. With a robust skill set that includes Product Registration, PMAs, Regulatory Strategy, Project Management, MDSAP and more. Don Guthner has 1 emails and 4 mobile phone numbers on RocketReach.
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