Med Tech Regulation
Director of Quality and Regulatory Affairs, OrganOx
Toni holds a BSc Honours degree in Biochemistry and a DPhil in Neuropharmacology from Oxford University. Previously Toni has worked for a number of start-up companies in the medical device, in vitro diagnostics and pharmaceutical arenas. She joined OrganOx Ltd in April 2011 to build the Quality Management System and the Regulatory Strategy.
Prior to this, Toni served 7 years at Oxford Immunotec Ltd, starting as a Senior Scientist working alongside the CEO and then through promotion to Director of Product Development, with line management responsibilities for 12 scientists and senior scientists. Toni has over 15 years experience in Product Development and Regulatory Submissions for both European and US approval. She can offer support and advice on the regulatory process required for CE Marking and medical device development.