Complaint Analyst

About the role

Overview The Complaint Analyst is responsible for the evaluation, investigation, documentation, and regulatory assessment of product complaints associated with medical devices.

What you'll do

• Independently conduct and document complaint investigations of moderate to high complexity by evaluating product performance concerns
• Coordinate and review product analysis, service evaluations, engineering assessments, and event coding activities to support complaint investigations
• Ensure complaint records are complete, accurate, and compliant with applicable procedures, regulatory requirements, and record retention requirements
• Assess complaint events for regulatory reportability using established decision models and investigation findings, and support the preparation, review
• Review service records, service reports, and other post-market information to assess whether events meet complaint criteria and verify appropriate complaint…

What you need

• Complaint handling
• Regulatory affairs
• Communication
• B.Tech or B.E.