We are proud to be working with a successful market leading consultancy located within the South East of England. They are looking for a Regulatory Affairs Specialist to join their dedicated team on a permanent basis. The right candidate will be responsible for providing regulatory knowledge within the sector, this includes the development, registration, post approval and efficient consulting services to their clients. The specialist will require to work directly with clients, handle tasks with minimum supervision and interact professionally at multiple levels within client organisations. This exciting role will also allow the right candidate to gain experience with medicines and drug-device combination products.
* 3-4 years of experience in the medical devices field of regulatory affairs
* Up-to-date knowledge on the EU Medical Device Directive and upcoming changes in the Regulation
* Working knowledge of ISO 13485 and have experience in maintaining a Quality Management System
* Good technical writing skills and be confident in preparing documents such as clinical evaluation reports, risk management plans and device labelling.
* Exposure to a wide variety of medical device projects (class I to III)
* Life Sciences Graduate or Pharmacist, ideally with a post-graduate qualification
* Good regulatory affairs experience including a successful track record in writing medical device technical files
* Knowledge of the medical device Directive/Regulation and MEDDEV guidelines
You will be expected to work independently on a day-to-day basis, have excellent written and verbal communication skills, good organisational and analytical skills, as well as excellent attention to detail. The successful candidate will also be fluent in written and spoken English.