Product Complaint Analyst II

Boston Scientific • Arden Hills, MN

3d

About The Position

Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Your responsibilities will include: Apply clinical knowledge, as related to product application, to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis. Establish regulatory reportability decisions using event investigation and regulatory decision models. Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations. Apply codes to events to facilitate product performance records.

Requirements

• Bachelor's degree
• Minimum of 2 years of experience in a health care, clinical, technical, scientific, and/or related field
• Knowledge of Left Atrial Appendage Closure 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

• Apply clinical knowledge, as related to product application, to evaluate identified complaints.
• Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
• Apply codes to events to facilitate product performance records.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees