Product Analyst II
Boston Scientific Corporation
- Learning how to complete an MDR.
- Combined my clinical knowledge with my technical understanding of devices to determine FDA reportability.
- Used my clinical background in cardiology to improve my coworker's technical understanding.
- Evaluate each event for FDA reportability.
- Coordinate the event information, device investigation, MDR creation, and medical investigation prior to closing an event/complaint in the complaint handling database.
- Contacting the sites, sales representatives or physician's to obtain more information and clarification of events.
- Assure the quality of all complaint information prior to closing an event/ complaint.