Jonathan Hughes, Ph.D., FTOPRA, is the Principal Consultant of JHRA Ltd. Jonathan has over 28 years of worldwide regulatory and clinical affairs experience across medical devices, combination products and human / veterinary pharmaceuticals. He has worked with medical device and pharmaceutical companies, both large and small, across multiple locations to help develop and execute regulatory strategies for market clearance, approval and access.
Jonathan has hands-on experience in a variety of therapeutic areas including woundcare / dermatology, urology, diabetes / endocrinology, oncology, pulmonary, orthopaedics and blood products. He has worked across different technologies and types of medical products including medicated devices (devices containing ancillary drug and biologic constituents), drug delivery systems and componentry, sterile and non-sterile disposables and durable equipment, software controlled devices and standalone software (including medical apps). Jonathan has experience of regulating medical devices and combination products across international markets including the European Union and Japan.
Jonathan specialises in regulatory strategy, regulatory and clinical development pathways, worldwide regulatory submissions and training. He has worked with all the major international regulatory agencies, in particular Notified Bodies and EU Competent Authorities, Japanese PMDA, US FDA, Chinese FDA.
Following completion of his PhD in veterinary pathophysiology, Jonathan began his career in regulatory affairs at A H Robins. He subsequently held regulatory affairs positions in drug and device companies, including Smith & Nephew, Glaxo, Bristol-Myers Squibb and ConvaTec. Jonathan has served on two European Commission Expert Working Groups on the Drug / Device Borderline and Device Classification. Jonathan is a Fellow of the regulatory professional organisation, TOPRA, and is a regular contributor on numerous educational and training programmes, delivering lectures and acting as advisor for two medical technology MSc courses (at the University of Hertfordshire and Cranfield University) and a biomedical science MSc course with Newcastle University.