Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Websites
Certification
Languages
Timeline
Generic
Sonu J M

Sonu J M

Nagercoil

Summary

Dedicated Product Complaint professional with over 2.5 years of experience in investigating medical device complaints and delivering customer responses. Proven ability to collaborate cross-functionally to meet regulatory milestones and enhance product sustainability. Expertise in addressing customer inquiries and resolving concerns to maximize satisfaction.

Overview

3
3
years of professional experience
1
1
Certification

Work History

Project Associate RA/QA

Elexes Medical Consultancy
Bangalore
10.2024 - Current
  • Demonstrated equivalence of various medical devices in compliance with EU MDR.
  • Performed segregation of Medical Device Reports from MAUDE database to analyze adverse event trends.
  • Developed checklist to ensure compliance with PSUR requirements per MDCG guidelines.
  • Contributed to strategy development meetings, coordinating alliances and brand recognition initiatives.

Product Regulatory Analyst

HCL Tech
Chennai
09.2022 - 10.2024
  • Led in-depth investigations of product complaints while aligning with internal procedures and international safety standards, ensuring proper documentation and traceability throughout the complaint lifecycle.
  • Evaluated potential safety risks associated with complaints, supporting global reporting decisions in line with FDA and international regulations.
  • Submitted incident summaries and safety communications to the appropriate regulatory bodies after assessing event severity and classification.
  • Followed up with internal teams and customers to collect missing data or clarify complaint details, helping to ensure complete and accurate case files.
  • Maintained clear, professional communication with customers during the investigation process, both in writing and through cross-functional calls.
  • Collaborated closely with lab analysts and manufacturing teams to retrieve and examine product samples, identify failure modes, and determine root causes.
  • Applied appropriate device issue codes using regulatory classification systems, and ensured consistency across complaint records.
  • Supported technical documentation updates and labeling projects through standards-based gap analysis (EN ISO 1041, ISO 15223).
  • Played a key role in EU MDR remediation activities, contributing to the transition of Class IIb device files from MDD to MDR compliance.
  • Tracked and analyzed complaint trends over time to highlight recurring product issues, and supported CAPA decisions by quality teams.
  • Coordinated with Medical Affairs to relay newly observed failure trends and helped prioritize safety monitoring efforts in investigation outcomes.
  • Delivered two analysis reports using the US FDA MAUDE database, which is a part of a specific Class III product's CAPA – 21 CFR 806.

Education

Bachelor's Degree - Biomedical Engineering

Jerusalem College of Engineering
Chennai, India
06-2022

Skills

  • TrackWise tool
  • ISO 13485 - MQMS
  • ISO 14971 - Risk Management
  • Communication
  • Incident reporting
  • Root cause analysis
  • Performance monitoring
  • Task prioritization
  • Time management
  • MS Office
  • Complaint investigation
  • Risk assessment
  • Cross-functional collaboration

Accomplishments

Star Performer- Regulatory Center of Excellence.

Languages

  • English
  • Tamil
  • Malayalam

Certification

  • Mini Course on EU MDR
  • Understanding Global Regulations
  • How medical devices are regulated in Health Canada
  • Certification on Drug Discovery

Languages

Tamil
First Language
English
Advanced (C1)
C1
Malayalam
Elementary (A2)
A2

Timeline

Project Associate RA/QA

Elexes Medical Consultancy
10.2024 - Current

Product Regulatory Analyst

HCL Tech
09.2022 - 10.2024

Bachelor's Degree - Biomedical Engineering

Jerusalem College of Engineering

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Sonu J M