Overview

The Complaint Analyst is responsible for the evaluation, investigation, documentation, and regulatory assessment of product complaints associated with medical devices. This role supports compliance with applicable global regulations and quality system requirements through complaint investigations, adverse event reportability assessments, complaint trending, risk escalation, and cross-functional collaboration to identify and mitigate patient safety and product quality risks.

Responsibilities
- Independently conduct and document complaint investigations of moderate to high complexity by evaluating product performance concerns, gathering information from customers, users, field representatives, and internal stakeholders, reviewing service records and product analysis findings, and exercising sound judgment to determine complaint conclusions and appropriate escalation activities.
- Coordinate and review product analysis, service evaluations, engineering assessments, and event coding activities to support complaint investigations, facilitate product performance monitoring,



and ensure consistent event categorization.
- 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, and documentation of MDR, Vigilance, and other applicable adverse event reports.
- Review service records, service reports, and other post-market information to assess whether events meet complaint criteria and verify appropriate complaint classification in accordance with applicable procedures and regulatory requirements.
- Analyze complaint, service, and performance data to identify emerging quality, safety, reliability, or compliance trends and appropriately escalate issues requiring CAPA, risk management review, regulatory assessment, or other

📌 Complaint Analyst (Madhapur)
🏢 OSI Systems
📍 Madhapur