Kathryn Jayne
- Role
- Senior Director, Quality Assurance and Regulatory Affairs at Acumed
- Location
- Dallas-Fort Worth, TX, US
- LinkedIn followers
- 500 followers
Manufacturing & ProductionView LinkedIn profile
About Kathryn Jayne
With my extensive experience in the medical device field and my passion for ensuring…
Experience
Senior Director, Quality Assurance and Regulatory Affairs
Dec 2020 — Present
Education
Oklahoma Baptist University
BS, Kinesiology and Exercise Science
1992 — 1996
Skills
- Medical Devices
- Clinical Research
- Quality Auditing
- Capital Equipment
- Product Launch
- Design of Experiments
- Clinical Trials
- Fda Gmp
- Ce Marking
- Qsr
- Iso
- Biotechnology
- Leadership
- Regulatory Affairs
- Change Control
- Validation
- Market Development
- Pharmaceutical Industry
- Gmp
- Surgery
- Management
- 21 Cfr Part 11
- Design Control
- Glp
- Quality Control
- Capa
- Regulatory Submissions
- Medical Device Directive
- Minitab
- Process Improvement
- R&D
- Hospitals
- Iso 14971
- Sop
- Hardware Diagnostics
- Quality System
- Fda
- V&V
- Iso 13485
- Quality Management
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