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Sue Werner Location
Rochester, NY, US
Sue Werner Work
Principal Consultant @ RegDx Consulting LLC (April 2023 - Present)
Head Of Regulatory Affairs @ (May 2022 - May 2023)
Director Regulatory Affairs - Molecular Diagnostics at Becton, Dickinson and Company @ (July 2020 - May 2022)
Senior Director of Regulatory and Quality @ (June 2017 - July 2020)
Regulatory Affairs Manager @ (November 1997 - June 2017)
Research Scientist @ (May 1988 - October 1997)
Sue Werner Education
University at Buffalo
BS (Molecular Biology)
1984-1988
Sue Werner Skills
PMA
Diagnostics
Regulatory Affairs
FDA
Medical Devices
510 K
Regulatory Submissions
Product Development
Infectious Diseases
Design Control
Compliance
QSR
Cross-functional Team Leadership
Quality Systems
Quality System
Quality Assurance
Project Management
Cross Functional Team
Customer Service
Strategic Planning
Cross Functional Team Leadership
Leadership
Sue Werner Summary
Sue Werner, based in Rochester, NY, US, is currently a Principal Consultant at RegDx Consulting LLC. Sue Werner brings experience from previous roles at Biocartis, BD, Saladax Biomedical Inc. and Ortho Clinical Diagnostics. Sue Werner holds a 1984 - 1988 BS in Molecular Biology @ University at Buffalo. With a robust skill set that includes PMA, Diagnostics, Regulatory Affairs, FDA, Medical Devices and more. Sue Werner has 1 emails and 1 mobile phone numbers on RocketReach.
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