Mary Hutchens - Regulatory Affairs

Mary graduated as a biologist and began her career working in the agrochemical industry. Having specialised in regulatory affairs, she moved into the medical device field in 2000. She has experience in the regulation of Medical Devices including IVDs in a variety of global markets, particularly in the EU and US.

Mary has worked for companies ranging from large multinationals to small start-ups. She has developed regulatory strategies for new products, encompassing the creation of Design History Files and compilation of Technical Files to satisfy essential requirements. She has also commissioned clinical trials for innovative products. By bringing this experience and these skills to bear at the heart of the product development process, our Medical Device and Pharmaceutical clients can benefit enormously.

Mary is based in North Hertfordshire and likes to spend her spare time gardening, cooking and searching for antiques, though not all at the same time.