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Sue Werner Location
Rochester, NY, US
Sue Werner Work
2023 -now Principal Consultant @ RegDx Consulting LLC
2022 -2023 Head Of Regulatory Affairs @
2020 -2022 Director Regulatory Affairs - Molecular Diagnostics at Becton, Dickinson and Company @
2017 -2020 Senior Director of Regulatory and Quality @
1997 -2017 Regulatory Affairs Manager @
1988 -1997 Research Scientist @
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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