2019 -
now Group Quality and Regulatory Director @
2018 -
2019 Director Of Quality Assurance and Regualtory Affairs @
2017 -
2019 Head of Quality Assurance and Regulatory Affairs @
2015 -
2017 VP Quality and Regulatory Affairs @
2012 -
2015 Regulatory Affairs and Quality Manager @
1999 -
2012 Group Quality Assurance and Regulatory Affairs Manager @
Amanda Makemson Skills
Regulatory Affairs
CE marking
ISO 13485
Medical Devices
CAPA
ISO 14971
Quality System
Design Control
GMP
Medical Device Directive
CMDCAS
IEC 60601
Technical Files
PMA
Management Review
Regulatory Requirements
Surgical Instruments
Product Launch
Complaint Management
Product Complaints
GxP
Quality Auditing
Validation
Cardiology
Capital Equipment
Disposables
Quality Assurance
FDA
Change Control
V&V
Sterilization
Regulatory Submissions
Product Development
Leadership
Public Speaking
Research
Management
Strategic Planning
Business Strategy
Amanda Makemson Summary
Amanda Makemson, based in United Kingdom, is currently a Group Quality and Regulatory Director at Kimal. Amanda Makemson brings experience from previous roles at Bright Hope in North West Leicestershire, SFM Ltd and Sphere Medical. With a robust skill set that includes Regulatory Affairs, CE marking, ISO 13485, Medical Devices, CAPA and more. Amanda Makemson has 4 emails on RocketReach.
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