Juliette CookVice President, Quality and Regulatory Affairs at Implantica Management AG
Juliette joined Cochlear Limited in 2017, heading the Regulatory Affairs function for the Europe, Middle East and Africa Region. Cochlear is a leading global medical device company that provides implant solutions to restore hearing. She is leading project activities to ensure compliance to the new Medical Device Regulation.
Prior to this she spent nearly 7 years at Rayner Intraocular Lenses as Director of Quality and Regulatory Affairs, managing the team responsible for global regulatory, quality and the company’s clinical programme. She was involved in key strategic projects including the construction and transfer to a new manufacturing facility, Notified Body change, new product development, quality remediation, company acquisitions and of course the MDR.
Previous roles include leading Regulatory Affairs with Zimmer in Switzerland, most notably the project to up-classify hip, knees and shoulders to class III. She has had diverse roles in managing research and development, quality management systems, medical device management and leading regulatory affairs teams both in the UK and overseas in developing countries, from big multinationals, to tiny companies.
She is a Chartered Mechanical Engineer, member of the Regulatory Affairs Professional Society and has been an active member of MedTech Europe and ABHI. She has a Doctorate qualification in Biomedical Engineering and has worked in Industry and the Global Healthcare Sector for over 20 years.