Complaints Specialist

The Complaints Specialist is responsible for receiving, documenting, investigating, and resolving product complaints in accordance with company policies, regulatory requirements, and industry standards. This role plays a critical part in ensuring compliance with applicable regulations, including FDA, ISO 13485, EU MDR, and other global requirements. The Complaints Specialist works cross-functionally with Quality, Regulatory, Engineering, and CMO’s to ensure timely and thorough complaint resolution and continuous product improvement. The role involves ensuring timely processing of complaints, communicating with healthcare providers, facilitating the complaints process by entering information into a database, participating in root cause investigations, coordinating meetings, contributing to procedure development, escalating issues, providing customer communication, evaluating complaint information for regulatory reporting, preparing reports for agencies, responding to inquiries, preparing trend reports, assisting with post-market surveillance, and maintaining confidentiality.