Remote clinical evaluation reports medical writer - (Santa Rosa, CA)

A communication solutions provider is filling a position for a Remote Clinical Evaluation Reports Medical Writer. Core Assignments include: Evaluating data for similar competitor devices Screening and summarizing literature for relevant clinical data Ensuring timely production of high-quality CERs for devices across therapeutic areas Must meet the following qualifications for consideration: Willingness to travel to India office up to 2 times a year Background across document types and therapeutic areas/diseases/drug classes 1-2 yrs of regulatory writing background, with some exposure to medical devices A MD, PhD in Biomedical Engineering or similar degree, a Master's degree with clinical research exposure can also be considered 5+ years of CER writing background in a medical device company, CRO, or agency Advanced knowledge of 510(k), MedDEV 2.7.1 Rev 4, MDR, and other relevant medical device regulations