Gwen Taschner
Senior Manager, Regulatory Affairs at JenaValve Technology, Inc.
- Role
- Senior Manager, Regulatory Affairs at JenaValve Technology, Inc.
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Gwen Taschner
Over 10 years of experience in Regulatory Affairs for the biotechnology industry with focus on Medical Device Regulations, Product Development, PMA/510(k) applications, Medical Devices, Active Implantables, Quality Assurance/Regulatory Strategy & Compliance (FDA, AIMD, MDD, & MDR), Risk Management and Regulatory Audit. Experience in leading multi-disciplinary teams (local, remote and outsourced). Strong interpersonal communication skills and team management.
Experience
Senior Manager, Regulatory Affairs
Sep 2024 — Present · Irvine, CA, US
Education
Drexel University
Bachelor of Science (BS), Materials Science and Engineering
1997 — 2002
Skills
- Design Control
- Plastics
- Validation
- Biotechnology
- Catheters
- Lean Manufacturing
- Medical Device Directive
- Iso 13485
- Iso
- Pharmaceutical Industry
- Sop
- Fda
- Biomaterials
- Supplier Quality
- Iso 14971
- Quality Assurance
- Design for Manufacturing
- Product Design
- Product Launch
- Quality Auditing
- Minitab
- Regulatory Affairs
- Biomedical Engineering
- Gmp
- Continuous Improvement
- 21 Cfr
- Fmea
- Dmaic
- Regulatory Submissions
- Manufacturing Engineering
- Quality System
- V&V
- Design of Experiments
- Quality Management
- Spc
- Solidworks
- Glp
- Root Cause Analysis
- Polymers
- R&D
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