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 global 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.
