Principal Regulatory Affairs Specialist @ Medtronic - Aortic, Peripheral and Venous (APV) (January 2016 - July 2021)
Sr. Regulatory Affairs Specialist @ (March 2014 - December 2015)
Regulatory Affairs Specialist @ (June 2012 - March 2014)
Senior Quality Systems Engineer @ (December 2009 - June 2012)
Quality Assurance Associate @ (January 2006 - December 2009)
Microbiology Technical Data Auditor @ Paddock Laboratories (January 2003 - January 2006)
Microbiology Technician II @ Paddock Laboratories (September 2001 - January 2003)
Microbiologist @ Part Three (May 2000 - September 2001)
Product Development Technical Specialist @ (July 1996 - May 2000)
Kim Wallner Education
University of Minnesota
B.S. (Microbiology)
Kim Wallner Skills
V&V
ISO 13485
Validation
FDA
CAPA
Regulatory Affairs
Process Improvement
Quality System
Remediation
ISO 14971
Microbiology
Regulatory Science
Sterilization
Configuration Management
Quality Assurance
Software Documentation
21 CFR
GMP
Regulatory Requirements
Quality Management
Design Control
Trackwise
Medical Devices
21 CFR Part 11
SQL
Leadership
Laboratory
Kim Wallner Summary
Kim Wallner, based in Saint Paul, MN, US, is currently a Senior Manager Regulatory Affairs at Medtronic. Kim Wallner brings experience from previous roles at Medtronic - Aortic, Peripheral and Venous (APV), Cardiovascular Systems, Inc., American Medical Systems and St. Jude Medical. Kim Wallner holds a B.S. in Microbiology @ University of Minnesota. With a robust skill set that includes V&V, ISO 13485, Validation, FDA, CAPA and more. Kim Wallner has 2 emails and 1 mobile phone numbers on RocketReach.
Looking for a different Kim Wallner?
Find contact details for 700 million professionals.