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 (México)
🏢 Emma of Torre.ai
📍 México