The primary function of a Senior Medical Writer / Senior Project Manager, Clinical Evaluation is to combine understanding of scientific and research methodology, medical device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, MDCG Guidance documents, and EU MDR 2017/745. Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).