Clinical Field Assurance Specialist II Job in Tempe, Arizona US
Accurately records and logs all complaint information from customers and internal employees into the electronic complaint handling database.
Records and reports complaints to manufacturers of distributed products as stated in distribution agreements.
Acknowledges receipt of complaint and generates closure letters, as appropriate.
Conducts complaint report-ability determinations (e.g., MDR, MDV and other global adverse event reporting regulatory).
Makes report-ability decisions, and completes regulatory reports (e.g., MDR, MDV, etc.).
May conduct quality checks, peer or final approvals of complaint files prior to closure.
Assures timely complaint closures, meeting both internal and external requirements and goals, by tracking complaint status, and samples from the customer thru to file closure.
Completes complaint file closure activities.
Continuously monitors complaints for potential trends.
Responsible for the secure and accurate maintenance of the complaint database.
Reviews medical records for event information to determine regulatory report-ability or to respond to corporate legal inquires. May also review medical images.
Supports Service Repair (as applicable).