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Steven Gauthier Location
Aurora, CO, US
Steven Gauthier Work
Principal Regulatory Affairs Specialist @ (July 2024 - Present)
Sr. Regulatory Affairs Specialist @ (January 2021 - July 2024)
Sr. Regulatory Affairs Specialist @ (April 2020 - January 2021)
Regulatory Affairs Specialist II @ (February 2019 - January 2020)
Regulatory Affairs Specialist @ (June 2016 - February 2019)
Sr. Regulatory Affairs Specialist @ (May 2012 - June 2016)
Regulatory and QA and QC Manager @ Colorado Quality Products Inc (June 2010 - July 2012)
Consumer Safety Officer @ (February 2009 - February 2010)
Researcher Associate IV @ (November 2004 - February 2009)
Steven Gauthier Education
Simpson College
Bachelor’s Degree
1998-2001
Steven Gauthier Skills
21 CFR
510(k)
Analytical Skills
Biotechnology
CE marking
Change Control
Communication
Continuous Process Improvement
Customer Quality
Design Control
Electronic Common Technical Document (eCTD)
Engineering Change
ISO 13485
ISO 14971
ISO Standards
In Vitro Diagnostics (IVD)
Knowledge Sharing
Management Review
Marketing Compliance
Medical Devices
Medical Science
New Hire Processes
Oral Communication
Performance Motivation
Premarket Approval (PMA)
Problem Solving
Product Quality
Project Management
Project Portfolio Management
Quality Assurance
Quality System Compliance
Regulated Industry
Regulatory Affairs
Regulatory Agencies
Regulatory Approvals
Regulatory Projects
Regulatory Standards
Regulatory Submissions
Relationship Development
Research Skills
Resource Allocation
Skill Development
Strategy
Team Leadership
Teamwork
Timelines
U.S. Food and Drug Administration (FDA)
Vendor Relations
Writing
Written Communication
Steven Gauthier Summary
Steven Gauthier, based in Aurora, CO, US, is currently a Principal Regulatory Affairs Specialist at Medtronic. Steven Gauthier brings experience from previous roles at Medtronic, Cochlear and Corgenix Medical Corporation. Steven Gauthier holds a 1998 - 2001 Bachelor’s Degree @ Simpson College. With a robust skill set that includes 21 CFR, 510(k), Analytical Skills, Biotechnology, CE marking and more. Steven Gauthier has 2 emails on RocketReach.
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