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Soumen Patra

Post Market Surveillance Specialist · Medical Device Complaint Handling

Jhargram, West Bengal, India

@soumen_patra

0 followers

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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

<3 months <3 months Just getting started - under three months. This is also what shows when a level has not been set.
SAP Excel TrackWise Salesforce Audit Readiness CAPA Management Complaint Handling Complaint Trending Root Cause Analysis Data Reconciliation Complaint Evaluation Regulatory Compliance Cross-functional Collaborations

Languages

Fluent Fluent Comfortable using it for work.
French Speak · Read English Speak · Read
Basic Basic A few words and simple phrases.
German Speak

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