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Stephanie Sheesley Location
York, PA, US
Stephanie Sheesley Work
2024 -now Senior Director, Device Development Operations @
2022 -2024 Director of Regulatory Affairs @
2018 -2022 Associate Director Regulatory Affairs @
2015 -2018 Manager, Regulatory Consulting @
2011 -2015 Senior Manager, Regulatory Affairs @
2010 -2011 Manager, Regulatory Affairs @
2007 -2010 Regulatory Affairs Specialist III @
2003 -2007 QA Final Release Supervisor @
2000 -2003 Scientist I @
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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