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Hayley Johnson Location
Cleveland, OH, US
Hayley Johnson Work
Regulatory Affairs Post Market Specialist @ (September 2026 - Present)
Senior Regulatory Affairs Specialist @ (October 2025 - August 2026)
Client Manager (QMS Auditor) @ (December 2021 - September 2025)
Assessor (QMS Auditor) @ (July 2021 - December 2021)
Regulatory Affairs Specialist @ Coltene Whaledent, Inc. (October 2020 - June 2021)
Product Engineer @ Coltene Whaledent, Inc. (March 2016 - October 2020)
Product Engineering Technician @ Coltene Whaledent, Inc. (July 2015 - March 2016)
Student Assistant @ (August 2009 - December 2013)
Hayley Johnson Education
Ashland University
Master of Business Administration - MBA (Executive Management)
2018-2019
The University of Akron
Bachelor of Science (Biomedical Engineering; Applied Mathematics)
2010-2014
Hayley Johnson Skills
62366
Aseptic Technique
Autodesk Inventor
Biomedical Engineering
Change Management
Clinical evaluation
Complaint Investigations
Corrective and Preventive Action (CAPA)
Customer Satisfaction
Data Analysis
Design Control
Design History
Engineering
Functional Testing
IEC 62304
ISO 13485
ISO 14971
ISO 9001:2015 Auditor
Internal Audit
MDSAP
Manufacturing
Matlab
Mechanical Testing
Medical Device Directive
Medical Device ISO 13485:2016 Auditor
Medical Device Regulation (MDR)
Medical Devices
Microsoft Project
Post Market Surveillance
Problem Solving
Product Development
Project Management
Quality Management
Quality System
Remediation
Research and Development (R&D)
Risk Analysis
Risk Management
Software Development Life Cycle (SDLC)
Stability Studies
Statistical Data Analysis
Statistics
Sterilization
Technical Files
U.S. Food and Drug Administration (FDA)
Hayley Johnson Summary
Hayley Johnson, based in Cleveland, OH, US, is currently a Regulatory Affairs Post Market Specialist at Oracle. Hayley Johnson brings experience from previous roles at ViewRay Systems, Inc., BSI and Coltene Whaledent, Inc.. Hayley Johnson holds a 2018 - 2019 Master of Business Administration - MBA in Executive Management @ Ashland University. With a robust skill set that includes 62366, Aseptic Technique, Autodesk Inventor, Biomedical Engineering, Change Management and more. Hayley Johnson has 1 emails and 2 mobile phone numbers on RocketReach.
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