Boston Scientific - Arden Hills, MN
posted 2 months ago
The Product Complaint Analyst evaluates customer complaints to determine which are regulatory reportable per the Code of Federal Regulations (CFR) and other international regulations. This role oversees all aspects of complaint handling, including the timely review of product feedback, analysis, and investigation to gather pertinent information and communicate findings through regulatory reporting and written communication to key stakeholders. The analyst plays a crucial role in ensuring that the company adheres to regulatory standards while maintaining high-quality product performance and customer satisfaction. In this position, you will be responsible for assessing incoming complaint information to determine eligibility for medical device and vigilance reporting. You will ensure that reports are complete, accurate, and submitted on time, while also ensuring that policies and procedures comply with FDA and international regulations. The role requires interfacing with end users and collaborating with internal and external contacts to collect complaint information, maintaining awareness of new products, government regulations, and requirements. Additionally, you will perform other duties as assigned, contributing to the overall success of the product complaint management process.