Following graduation in 1994 with a degree in Applied Biological Sciences, specialising in immunology and medical microbiology, my first role was a Development Scientist in R&D with a company in Liverpool, UK that manufactures vaccines. I was part of a small team led by Dr Margaret Brady, working on a new type of influenza vaccine that was self-administered by inhalation, for people who were uncomfortable with needles. I made the world’s first clinical trial batches of this vaccine, and today it is sold by Novartis Ltd as FluMist®.
In 2002 I switched from the pharmaceutical industry to the medical devices industry, starting as a project manager for the CE Marking of a tissue-bulking Class III implant made from sterile decellularised, micronised pig collagen in saline called Permacol® Injection. Since then, I have worked on the design, development and launch of all classes of medical devices in worldwide markets. I specialise in implants made from biological tissues, for cardiovascular and orthopaedic intended use. I have held management roles at a variety of SMEs including Manufacturing Manager, Development Manager, Regulatory Affairs Manager and Project Manager. I have also worked at the Notified Body BSI as a Technical Specialist and Scheme Manager, and as a consultant with Maetrics Ltd.
I now offer my services to industry as an independent consultancy, to assist with new product development, Regulatory strategy, writing and implementing Quality Management Systems in accordance with BS EN ISO 13485, creating risk management files and clinical evaluations.