Regulatory Affairs Manager

Our client a global Medical Device manufacturing company specialising in Fem Tech are looking for a Regulatory Affairs Manager to join an exiting team reporting to the Director of Regulatory Affairs. The company produce equipment, consumable medical devices and general laboratory equipment. A cross functional role the chosen candidate will work with internal and international teams/departments. The company will offer hybrid or remote working for those further away if needed. Summary: The Regulatory Affairs Manager is responsible for regulatory strategy to attain and maintaining EU, US and UK device certifications and market clearance regulatory assessment of changes to devices, process, supply chain and regulations, and resultant notification and re-registration activities proactively monitoring changes in EU and UK medical device regulations, and share or provide training to global Regulatory Affairs teams, commercial, distribution and service teams UKCA mark compliance and MHRA registration and listing Skills: Management, support and development of RA team members responsible for creation and maintenance of Technical Documentation Files, Device History Files The Regulatory Affairs Manager will be managing RA projects and define strategy for new product development, maintenance of legacy device portfolio, acquisitions, etc. Proactively monitor c…