Vice-President, Regulatory Affairs, Quality Assurance and Clinical Affairs @ (June 2021 - June 2024)
Vice-President, Regulatory Affairs, Quality Assurance and Clinical Affairs @ (January 2019 - May 2021)
Regulatory Affairs Consultant @ Medical Device Industry (August 2018 - January 2019)
Vice-President, Regulatory Affairs and Quality Assurance @ 4Tech Cardio, Ltd. (March 2016 - July 2018)
Vice-President, Regulatory Affairs, Quality Assurance and Clinical Affairs @ CardiAQ Valve Technologies, Inc. (acquired by Edwards Lifesciences) (January 2014 - January 2016)
Vice-President, Regulatory Affairs and Quality Assurance @ Cardiac Dimensions, Inc. (January 2008 - December 2013)
Vice-President, Regulatory Affairs and Quality Assurance @ (August 2001 - December 2007)
Sr. Regulatory Project Director @ Regulatory & Clinical Research Institute, Inc. (RCRI) (December 2000 - August 2001)
Manager of Regulatory Affairs @ (September 1999 - December 2000)
Director, Regulatory Affairs and Compliance @ (November 1996 - September 1999)
Regulatory Affairs Coordinator @ Telectronics Pacing Systems (acquired by St. Jude Medical) (May 1995 - October 1996)
Regulatory Affairs Specialist @ Aequitron Medical, Inc. (May 1994 - May 1995)
Quality Assurance and Regulatory Affairs Representative @ (January 1992 - April 1994)
Paul Cornelison Education
University of Pennsylvania
Master of Science (Engineering (Management of Technology))
2002-2005
Saint John's University
Bachelor of Arts (B.A.) (Management / Spanish)
1982-1986
Paul Cornelison Skills
Regulatory Affairs
V&V
Product Launch
Medical Devices
Quality System
Clinical Trials
Quality Assurance
ISO 13485
Design Control
FDA
CAPA
ISO 14971
Staff Development
Regulatory Submissions
Validation
Medical Device Directive
21 CFR Part 11
Healthcare
Strategic Planning
Process Improvement
Regulatory
Management
Clinical Affairs
Corrective and Preventive Action
Paul Cornelison Summary
Paul Cornelison, based in Minneapolis, MN, US, is currently a Vice-President, Regulatory Affairs, Quality Assurance and Clinical Affairs at inQB8 Medical Technologies LLC. Paul Cornelison brings experience from previous roles at CorWave, Cardiac Implants LLC, Medical Device Industry and 4Tech Cardio, Ltd.. Paul Cornelison holds a 2002 - 2005 Master of Science in Engineering (Management of Technology) @ University of Pennsylvania. With a robust skill set that includes Regulatory Affairs, V&V, Product Launch, Medical Devices, Quality System and more. Paul Cornelison has 4 emails and 2 mobile phone numbers on RocketReach.
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