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Amanda Williams Location
Denver, CO, US
Amanda Williams Work
Sr Vice President of Clinical and Regulatory, Selution SLR @ (August 2023 - Present)
Member Board Of Directors @ (April 2022 - Present)
Senior Vice President of Clinical, Regulatory and Quality @ (September 2018 - May 2023)
Head of Regulatory Image Guided Therapy - Devices and Systems @ (December 2017 - September 2018)
Vice President @ Spectranetics (August 2013 - December 2017)
Sr. Director of Clinical and Regulatory Affairs @ Spectranetics (July 2010 - August 2013)
Director, Regulatory Affairs @ (October 2003 - June 2010)
Amanda Williams Education
Northeastern University
Master of Science (Regulatory Affairs - Drugs, Biologics and Medical Devices)
2008-2011
University of Minnesota Duluth
BS (Chemistry)
1995-1999
Amanda Williams Skills
Medical Devices
Regulatory Affairs
FDA
ISO 13485
Design Control
PMA
CAPA
V&V
Quality System
ISO 14971
Clinical Trials
Validation
Regulatory Submissions
Sop
GMP
GLP
GCP
Lifesciences
CE marking
Promotional and Labeling Materials
Team Leadership
Clinical Monitoring
Oncology
Orthopedic
Regulatory Requirements
Hardware Diagnostics
Commercialization
21 CFR Part 11
Vascular
ICH-GCP
Change Control
Cardiology
CRO
Cross-functional Team Leadership
Protocol
Medical Writing
ISO
Quality Auditing
Biopharmaceuticals
Pharmaceutical Industry
Clinical Research
Computer System Validation
FDA GMP
Product Launch
CTMS
Regulations
Product Development
R&D
EDC
GxP
Amanda Williams Summary
Amanda Williams, based in Denver, CO, US, is currently a Sr Vice President of Clinical and Regulatory, Selution SLR at Cordis. Amanda Williams brings experience from previous roles at Aclarion, ViewRay, Inc., Philips and Spectranetics. Amanda Williams holds a 2008 - 2011 Master of Science in Regulatory Affairs - Drugs, Biologics and Medical Devices @ Northeastern University. With a robust skill set that includes Medical Devices, Regulatory Affairs, FDA, ISO 13485, Design Control and more. Amanda Williams has 1 emails and 1 mobile phone numbers on RocketReach.
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