Product Surveillance Tech I
Job description:Investigate and maintain complaint files, following complaint handling regulation 21 CFR 820.198 and internal procedures. Analyze information obtained and make decisions for reportability under MDR regulation, 21 CFR 803 and international regulations.Initiate and set up complaint files. Maintain and update database. Record all complaint activity in both hard copy (when applicable) and computer files. Conduct regulatory reporting in accordance with applicable regulations, Retrieval Program, and internal trending. Make reportability decisions within specified timelines.Assess incoming documentation for complaint data and ascertain compliance to product specification and/or intended use as indicated in the product labeling. Evaluate internal and external lab analysis. Interface with device analysis lab regarding analysis results and processing complaints.Review adverse events reported in clinical studies to determine if events meet the regulatory definition of potentially reportable event or complaint.
Posted 111 days ago