Sr Spec Clinical Product Surveillance

Job Summary Under minimal supervision, use knowledge of clinical workflow and product use in assessing incoming complaints and hazards. Assist in post-market reportability determination. Leads clinical investigations for reported product incidents and submit adverse event reports. Provides clinical resource support to customers, sales reps and the product division for clinical issues. Identify hazardous situations from product design, product/material assessments, and customer complaints. Responsible for mentoring and coaching the Clinical Product Surveillance team. Job Description MAJOR RESPONSIBILITIES: Identify and evaluate complaints which affect patient safety. Prepare and submit Medical Device Reports (MDRs) and drug adverse event reports to the FDA.…