Complaint HandlingPostmarket Surveillance Analyst Sylmar CA Contract Communicates verbally and in writing both internally and externally to field representatives regarding information needed specific to product complaints (e.g. physicians, hospital personnel, sales representatives, international offices). Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned. Independently performs investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints. Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes, consulting as needed with management. Is diligent of any unusual trends in product complaints and communicates them to management. Archives complaint records and retrieves information on closed investigations. Ensures accurate department procedures and work instructions are maintained. Provide support to the Legal Department regarding product complaints. Supports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.