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Stephen Beier Location
New York, NY, US
Stephen Beier Work
Senior Principal Regulatory Affairs Specialist @ (December 2024 - Present)
Principal Regulatory Affairs Specialist @ (October 2022 - December 2024)
Regulatory Affairs Manager @ (March 2022 - October 2022)
Regulatory Affairs Principal Specialist @ (December 2019 - March 2022)
Regulatory Affairs Manager @ (February 2019 - December 2019)
Interim Director, Site Quality and Compliance @ (May 2018 - January 2019)
Manager, Quality Engineering and Quality Assurance, External Manufacturing @ (June 2015 - January 2019)
Senior Quality Engineer @ (January 2013 - June 2015)
Senior Specialist, Regulatory Affairs @ (July 2012 - January 2013)
Specialist, Regulatory Affairs @ (June 2011 - July 2012)
Regulatory, Quality and Clinical Affairs Associate @ (June 2009 - July 2011)
Stephen Beier Education
Northeastern University
MS (Regulatory Affairs for Drugs, Biologics, and Medical Devices)
2011-2013
The College of New Jersey
BS (Biomedical Engineering)
2004-2008
Stephen Beier Skills
Regulatory Affairs
FDA
Medical Devices
ISO 13485
Design Control
Validation
CAPA
Biomedical Engineering
GMP
V&V
Quality System
Biotechnology
21 CFR Part 11
R&D
Analysis
21 CFR
Lifesciences
Pharmaceutical Industry
Product Launch
Change Control
Design of Experiments
GxP
Sop
Clinical Research
Clinical Trials
Quality Assurance
Minitab
Six Sigma
CE marking
Product Development
Labview
FDA GMP
Biomaterials
Life Sciences
Project Closeout
Verification and Validation (V&V)
U.S. Food and Drug Administration (FDA)
Stephen Beier Summary
Stephen Beier, based in New York, NY, US, is currently a Senior Principal Regulatory Affairs Specialist at Medtronic. Stephen Beier brings experience from previous roles at Medtronic, Werfen North America and ZOLL Medical Corporation. Stephen Beier holds a 2011 - 2013 MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices @ Northeastern University. With a robust skill set that includes Regulatory Affairs, FDA, Medical Devices, ISO 13485, Design Control and more. Stephen Beier has 4 emails and 1 mobile phone numbers on RocketReach.
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