Description
- The Clinical Affairs Consultant III role will be responsible for performing Clinical Evaluations and writing/updating Clinical Evaluation Reports (CERs), associated documents, templates, and processes in compliance with MEDDEV 2.7.1 Rev. 4 and the European Medical Device Regulation (EU MDR). If a candidate has this specific experience, they will likely be a fit for the role as the required experience will already be in place based on having done this type of work before.
- The candidate should have excellent written and verbal communication skills, possess a strong sense of responsibility and urgency, and have a minimum of 5 years direct experience performing Clinical Evaluations and writing CERs compliant with MEDDEV 2.7.1. Familiarity with EU MDR requirements for CERs is a plus. This position requires the ability to interpret data from scientific literature and clinical studies and summarize the results and in a clear, concise, and scientifically accurate manner in the CER.