Associate MDR / Vigilance Specialist

Apply policies and procedures to comply with FDA and OUS regulations while monitoring the company's medical device surveillance program. Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility, ensuring complete and timely submission of required reports. Process adverse event reports through intake, protocol development, evaluation, and follow-up to support complaint closure activities. Interface with internal and external contacts to collect complaint information efficiently and maintain awareness of new product regulations. Act as a liaison to develop programs and processes meeting regulatory reporting requirements. This role supports the Galway Complaint Handling and Regulatory Reporting Department within the Customer Quality and Experience Management group.