Vice President Regulatory Affairs Quality Assurance @ (May 2022 - May 2024)
Senior Director Regulatory Affairs @ (July 2021 - May 2022)
Director of Regulatory Affairs @ (January 2020 - July 2021)
Sr Regulatory Affairs Manager @ (August 2018 - December 2019)
Regulatory Affairs Manager @ (September 2016 - August 2018)
Regulatory Affairs Manager @ (March 2015 - August 2016)
Project Regulatory Affairs Manager @ (December 2012 - March 2015)
Quality Assurance Project Manager @ (October 2011 - March 2015)
QA System Test Manager @ (November 2006 - March 2015)
Laboratory Technician @ LSNE Inc. (January 2004 - December 2006)
Kara Johnson Education
Northeastern University
Master's degree (Regulatory Affairs in Drugs, Biologics and Medical Devices)
2011-2012
Mount Holyoke College
(2) BA (BA in Each: Physics and English)
2000-2004
Derryfield
Kara Johnson Skills
Medical Devices
CAPA
Quality System
Design Control
Design for Manufacturing
Design of Experiments
Electronics
FDA
Testing
Quality Assurance
Manufacturing
Root Cause Analysis
ISO 13485
R&D
Regulatory Affairs
Software Documentation
Product Development
GMP
Validation
V&V
FMEA
Quality Management
Data Analysis
Public Speaking
PowerPoint
Strategic Planning
Process Improvement
Kara Johnson Summary
Kara Johnson, based in Manchester, NH, US, is currently a VP of Regulatory Affairs at Kapstone Medical. Kara Johnson brings experience from previous roles at Kapstone Manufacturing, KJ RAQA Consulting LLC, Casana and Conformis. Kara Johnson holds a 2011 - 2012 Master's degree in Regulatory Affairs in Drugs, Biologics and Medical Devices @ Northeastern University. With a robust skill set that includes Medical Devices, CAPA, Quality System, Design Control, Design for Manufacturing and more. Kara Johnson has 2 emails and 2 mobile phone numbers on RocketReach.
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