I'm helping qvalfocus.com find a top candidate to join their team full-time for the role of Remediation Complaint Analyst – Medical Devices.
You will ensure patient safety and product quality by leading critical complaint investigations.
Compensation:
INR 10 - 15/year
Location:
Remote (anywhere)
Mission of qvalfocus.com:
"Our mission is to help regulated organizations achieve operational excellence and compliance through expert guidance, structured execution, and reliable solutions that ensure quality, clarity, and lasting performance."
What makes you a strong candidate:
You have +6 years experience in Quality assurance (QA).
You are proficient in Technical documentation, Regulatory compliance, Data analysis, Complaint management.
English - Conversational
Responsibilities and more:
Job Summary:
The Complaint Analyst is responsible for the intake, review, investigation, and documentation of product complaints in accordance with applicable regulatory requirements and internal quality procedures.
This role supports the post-market surveillance process by ensuring timely evaluation, investigation, and closure of complaints while maintaining compliance with FDA regulations, ISO 13485, and other applicable quality system requirements.
Key Responsibilities:
Review, document, and process product complaints received from customers, field service teams, and distributors.
Perform complaint intake and ensure accurate documentation of complaint details within the complaint handling system.
Conduct initial complaint assessments to determine severity, reportability, and investigation requirements.
Perform complaint investigations including review of device history records, service records, and failure data.
Support the determination of Medical Device Reporting (MDR) or regulatory reporting requirements when applicable.
Code complaints using appropriate complaint classification systems (e.g.,



IMDRF coding).
Coordinate with cross-functional teams including Quality, Regulatory Affairs, R&D;, Manufacturing, and Service to support complaint investigations.
Ensure complaints are processed and closed within established timelines and quality system requirements.
Support complaint trending activities and assist in identifying potential product quality signals.
Maintain accurate and complete documentation in compliance with FDA 21 CFR Part 820, ISO 13485, and company procedures.
Participate in internal audits and regulatory inspections related to complaint handling processes.
Support post-market surveillance activities and provide complaint data summaries as required.
Required Qualifications:
Bachelor's degree in Engineering, Life Sciences, Biomedical, or related technical discipline.
6-10 years of experience in complaint handling, post-market surveillance, or quality assurance within a regulated industry.
Experience working within medical device or pharmaceutical quality systems is preferred.
Familiarity with FDA 21 CFR Part 820 and ISO 13485 requirements and FDA 483 remediation or EU MDR remediation.
Experience working with complaint management systems (Track Wise, Veeva, Salesforce, or similar).
Strong analytical and problem-solving skills.
Excellent documentation and technical writing abilities.
Preferred Qualifications:
Experience with Medical Device Reporting (MDR) or Vigilance reporting.
Knowledge of IMDRF complaint coding.
Exposure to CAPA processes and root cause analysis.
Experience supporting post-market surveillance activities.
Familiarity with regulatory requirements including FDA, EU MDR, and general vigilance reporting.
Key Skills:
Complaint investigation and documentation.
Regulatory compliance and quality systems.
Data analysis and complaint trending.
Cross-functional collaboration.
Technical documentation and reporting.
Your potential leader:
Raj

📌 Remediation Complaint Analyst - Medical Devices (Ciudad de México)
🏢 Emma of Torre.ai
📍 Ciudad de México