Medical Writer - Medical Device - (Mansfield, MA)

The Scientific Communications Medical Writer is a member of the Medical Segment Medical Affairs team and is responsible for researching, creating, editing and coordinating the production of clinical documents; with a focus on Clinical Evaluation Reports and Safety Reports required for CE marked devices. Essential duties and responsibilities: Write clinical evaluation reports (CERs) and post market surveillance summaries for CE marked devices Work with internal teams to gain cross-functional inputs and approvals Support periodic and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives. Develop and manage CER project plans and timelines. Plan and deliver intra-departmental and cross-functional communication to ensure critical info is transmitted to relevant parties in a timely manner. Perform periodic reviews of risk documentation, product labeling, and marketing claims as part of the clinical evaluation process.