Product Complaint Analyst II

Boston Scientific - Arden Hills, MN

Full-time - Mid Level

Arden Hills, MN

Miscellaneous Manufacturing

About the position

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.

Responsibilities

• Assessing incoming complaint information to determine eligibility for medical device and vigilance reporting; ensure reports are complete, accurate, and submitted on time
• Ensuring policies and procedures comply with FDA and international regulations
• Interfacing with end users and collaborating with internal and external contacts to collect complaint information
• Maintaining awareness of new products, government regulations, and requirements
• Performing other duties as assigned

Requirements

• Bachelor's degree in any engineering or science related discipline
• Minimum 2 years of experience working in medical device or similarly regulated industry
• Minimum 2 years of experience investigating product quality and patient-related complications (i.e serious injury)

Nice-to-haves

• Experience with TrackWise complaint handling system
• Experience managing regulatory submissions for medical device and vigilance reports (MDR/MDV)
• Knowledge of electrophysiology or ablation medical devices
• Strong interpersonal skills with the ability to work with cross-functional teams
• Organized and detail-oriented; ability to prioritize and manage competing priorities
• Strong written and verbal communication skills with ability to present technical information
• Effective problem-solving and critical thinking analytical skills; results-driven
• Self-driven and self-motivated to learn and knowledge to produce results