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Don Guthner Location
Douglassville, PA, US
Don Guthner Work
2024 -now Regulatory Affairs Consultant @
2021 -2024 Regulatory Affairs Specialist @
2020 -2021 Regulatory Affairs Manager @
2020 -2020 Global Regulatory Affairs Management Medical Devices @ Seeking a New Opportunity
2019 -2020 Regulatory Affairs Manager @
2007 -2018 Principal and Owner @ ORGENIX, LLC
2004 -2006 Principal @ ORCA, LLC
2001 -2004 Vice President and Founder @ MCRA, LLC
1983 -1990 Group Leader and Sr. CRA @ IOLAB
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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