Product Complaint Analyst II

Your responsibilities will include: Apply policies and procedures to comply with FDA and OUS regulations Evaluate incoming information for Medical Device Reporting and Vigilance reporting eligibility Ensure complete, accurate, and timely submission of Medical Device Reports (MDRs) and Vigilance Reports (MDVs) Perform other duties as assigned Bachelor's degree Minimum of 2 years of experience in a health care, clinical, technical, scientific, and/or related field Knowledge of Electrophysiology or ablation Interventional Cardiology medical devices Experience with TrackWise -based complaint handling system Submissions of MDRs and MDVs Experience evaluating and investigation patient complication/death events Medical device industry experience Post market/Quality Attention to detail Critical thinking skills Excellent written and verbal communication skills Self-motivated, goal-driven and results-oriented team player