Product Compliance Specialist

We are seeking an experienced Product Surveillance/Complaint Specialist. Working under general supervision, the Specialist receives, reviews, evaluates, investigates, and resolves medical device complaints. Maintains quality documents to ensure compliance with various regulatory agencies. Analyzes complaint data and trends. Coordinates the resolution of complaints and ensures that timely investigations are performed. Provides feedback to the development, manufacturing, and quality teams on potential product improvements for medical products. Prepares and files Medical Device Reports as appropriate to the U. S. Food & Drug Administration (FDA) and Health Canada (HC). Generates customer letters upon completion of investigation as appropriate.