A really exciting, global Medical Device manufacturer are currently looking for a Clinical Affairs Specialist to join them on a permanent basis.
Clinical Affairs Specialist Role
This is a niche and interesting role that has cropped up due to the evolving nature of MEDDEV regulations in the past few years. Main job duties would include: compiling, updating and maintaining medical device technical file clinical evaluation reports (CERs) to MEDDEV 2.7/1 Rev. 4; assisting with planning and coordination of post-market clinical follow-up (PMCF) studies to MDR 2017/745 and assisting with pre-market clinical investigation planning, submissions and execution
Clinical Affairs Specialist Requirements
– Educated to degree level in relevant discipline (science or healthcare)
– Working knowledge of MEDDEV 2.7/1 Rev.4
– Ability to learn and understand clinical procedures in order to evaluate clinical literature
– Experience with clinical trials in medical devices industry
– Understanding and experience of working to the requirements of EN ISO 14155 ‘Clinical investigation of medical devices for human subjects — Good clinical practice’ including a sound understanding of the creation of clinical study protocols
– Knowledge of the Post-market surveillance requirements of Annex XIV Part B of MDR 2017/745
– Experience of preparing submissions to ethics committees
This role is based in the North East, but can also be carried out remotely, with quarterly trips into the office.
If this role sounds like it could be of interest, please do apply.