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Product Complaint Analyst II at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Jan, 26

Salary

0.0

Posted On

04 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Attention To Detail, Critical Thinking, Written Communication, Verbal Communication, Self-Motivated, Goal-Driven, Results-Oriented, Team Player, Electrophysiology, Ablation, Interventional Cardiology, TrackWise, Medical Device Reporting, Vigilance Reporting, Patient Complication Evaluation, Medical Device Industry

Industry

Medical Equipment Manufacturing

Description

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

Responsibilities

The Product Complaint Analyst II will apply policies and procedures to ensure compliance with FDA and OUS regulations, evaluate incoming information for Medical Device Reporting, and ensure timely submission of reports. Additional duties may be assigned as needed.