Soumen Patra

About

Post Market Surveillance Specialist with 4+ years of experience in medical device complaint handling, MDR reporting, and regulatory compliance across FDA, EU MDR, and ISO 13485 requirements. Experienced in complaint investigation, root cause analysis, CAPA, and cross-functional collaboration to improve quality systems and patient safety.

Experience

• Lead Engineer – Post Market Surveillance
  HCL Technologies Ltd
  Mar 2025 – Mar 2026
• Complaint Evaluator & Investigator – Post Market Surveillance
  Wipro Limited
  Jun 2022 – Feb 2025

Skills

• Salesforce
• SAP
• Cross-functional Collaboration
• Root Cause Analysis
• Excel
• Regulatory Compliance
• Data Reconciliation
• CAPA
• Audit Readiness
• Complaint management
• TrackWise
• Medical device complaint handling
• Complaint Evaluation
• Complaint Trending

🗣️ Languages

• English · Fluent
• French · Fluent
• German · Basic