Senior Medical Writer

Role: Clinical Regulatory Writer supporting medical device product line compliance and regulatory documentation. Responsibilities: prepare clinical regulatory documents (e.g., annual reports, study summaries), support regulatory submissions and maintenance, coordinate data for MDR compliance, manage clinical study reports, protocols, and literature reviews; liaise with investigators, vendors, and CROs; oversee project timelines and budgets. Requirements: BS/MS in biological sciences, epidemiology, engineering, or related field; 3-4 years of medical/biomedical writing experience; knowledge of medical device regulations, clinical evaluation reports, and post-market requirements; proficient in literature searches, data management, and medical writing. Preferred: strong communication skills, project management ability, experience with clinical studies in device contexts. High-Value: focus on regulatory writing for medical devices, clinical data documentation, MDR compliance, collaboration with investigative sites and CROs. WorkSetup: not specified, likely hybrid or on-site given the nature of clinical coordination.