Amanda Makemson Email & Phone Number
Group Quality and Regulatory Director @ Kimal
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Amanda Makemson Location
- United Kingdom
Amanda Makemson Work
- Group Quality and Regulatory Director @ (March 2019 - Present)
- Member Board of Trustees @ (May 2024 - Present)
- Director Of Quality Assurance and Regualtory Affairs @ (March 2018 - March 2019)
- Head of Quality Assurance and Regulatory Affairs @ (August 2017 - March 2019)
- VP Quality and Regulatory Affairs @ (April 2015 - August 2017)
- Regulatory Affairs and Quality Manager @ (December 2012 - March 2015)
- Group Quality Assurance and Regulatory Affairs Manager @ (September 1999 - December 2012)
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 2 emails on RocketReach.
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