Stephanie Sheesley Email & Phone Number
Senior Director, Device Development Operations @ Akouos
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Stephanie Sheesley Location
- York, PA, US
Stephanie Sheesley Work
- Senior Director, Device Development Operations @ (May 2024 - Present)
- Director of Regulatory Affairs @ (April 2022 - May 2024)
- Associate Director Regulatory Affairs @ (November 2018 - April 2022)
- Manager, Regulatory Consulting @ (November 2015 - November 2018)
- Senior Manager, Regulatory Affairs @ (November 2011 - November 2015)
- Manager, Regulatory Affairs @ (August 2010 - November 2011)
- Regulatory Affairs Specialist III @ (December 2007 - August 2010)
- QA Final Release Supervisor @ (January 2003 - January 2007)
Stephanie Sheesley Education
- York College of Pennsylvania
B.S. (Biology)
1995-1998
Stephanie Sheesley Skills
- CAPA
- GMP
- Regulatory Affairs
- FDA
- ISO 13485
- Design Control
- Regulatory Submissions
- Medical Devices
- V&V
- Quality System
- Document Management
- ISO
- Change Control
- Quality Assurance
- Regulatory Requirements
- Validation
- ISO 14971
- Pharmaceutical Industry
- 21 CFR Part 11
- R&D
- Sop
- GLP
- CE marking
- U.S. Food and Drug Administration (FDA)
- ISO Standards
- Research and Development (R&D)
- Corrective and Preventive Action (CAPA)
- Standard Operating Procedure (SOP)
- Consulting
- Regulatory
- Corrective and Preventive Action Capa
- Research and Development R&d
- u.s. Food and Drug Administration Fda
- Standard Operating Procedure Sop
- u.s. Food and Drug Administration
- Research and Development
- Corrective and Preventive Action
- Standard Operating Procedure
Stephanie Sheesley Summary
- Stephanie Sheesley, based in York, PA, US, is currently a Senior Director, Device Development Operations at Akouos. Stephanie Sheesley brings experience from previous roles at Parexel and Integra LifeSciences. Stephanie Sheesley holds a 1995 - 1998 B.S. in Biology @ York College of Pennsylvania. With a robust skill set that includes CAPA, GMP, Regulatory Affairs, FDA, ISO 13485 and more. Stephanie Sheesley has 2 emails and 2 mobile phone numbers on RocketReach.
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