Location Leicester, Leicester, United Kingdom Regions Europe, Middle East, and Africa (EMEA) Gender Female
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Amanda has over 15 years’ industrial experience in the development of Medical Devices ranging from Class I through to Class III, along with the submission and maintenance of certification to the MDD & ISO13485 standards. She also has experience and knowledge of Pharmaceutical manufacturing (cGMP & GLP). She has been accountable for
development, implementation and ongoing quality compliance for UK and International sites and built a portfolio of products with approvals for global sales. This along with significant experience of liaising with Notified Bodies & Competent Authorities. Prior to joining Sphere, Amanda worked at Xstrahl and Kimal in Quality and Regulatory Affairs roles. Amanda is particularly interested in technology as it applies to healthcare delivery in current and emerging markets and the challenges the future holds for healthcare across the world.
