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Kathryn Jayne Location
Texas, United States
Kathryn Jayne Work
Vice President Quality Assurance and Regulatory Affairs @ (June 2024 - Present)
Senior Director, Quality Assurance and Regulatory Affairs @ (December 2020 - June 2024)
Director of Regulatory Affairs @ (October 2019 - December 2020)
Regulatory Affairs Manager @ (January 2018 - October 2019)
Senior Regulatory Affairs Lead @ (March 2017 - January 2018)
SR Regulatory Affairs @ (November 2015 - March 2017)
Director, Regulatory Affairs and Quality Assurance @ (January 2015 - November 2015)
Project Director @ Ken Block Consulting (March 2014 - January 2015)
RA and QA Manager @ SomnoMed, Inc. (November 2011 - February 2014)
Manufacturing Systems Manager @ (January 2011 - November 2011)
Compliance Manager @ (June 1996 - September 2011)
Regulatory and Doc Ctrl Manager @ (June 2002 - January 2010)
Kathryn Jayne Education
Oklahoma Baptist University
BS (Kinesiology and Exercise Science)
1992-1996
Kathryn Jayne Skills
21 CFR Part 11
Biomedical Engineering
Biotechnology
CAPA
CE marking
Capital Equipment
Cardiology
Change Control
Clinical Research
Clinical Trials
Cross-functional Team Leadership
Design Control
Design of Experiments
FDA
FDA GMP
GLP
GMP
Hardware Diagnostics
Healthcare
Hospitals
ISO
ISO 13485
ISO 14971
ISO Standards
Leadership
Management
Market Development
Medical Device Directive
Medical Devices
Minitab
PMA
Pharmaceutical Industry
Process Improvement
Product Development
Product Launch
QSR
Quality Assurance
Quality Auditing
Quality Control
Quality Management
Quality System
Quality Systems
R&D
Regulatory Affairs
Regulatory Requirements
Regulatory Submissions
Sop
Surgery
V&V
Validation
Kathryn Jayne Summary
Kathryn Jayne, based in Texas, United States, is currently a Vice President Quality Assurance and Regulatory Affairs at Acumed. Kathryn Jayne brings experience from previous roles at Acumed and OsteoMed. Kathryn Jayne holds a 1992 - 1996 BS in Kinesiology and Exercise Science @ Oklahoma Baptist University. With a robust skill set that includes 21 CFR Part 11, Biomedical Engineering, Biotechnology, CAPA, CE marking and more. Kathryn Jayne has 4 emails and 1 mobile phone numbers on RocketReach.
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