Complaint Handling Specialist

Job Summary

A company is looking for a Post-Market Surveillance / Complaint Handling Specialist.

Key Responsibilities

• Conduct end-to-end complaint handling activities and ensure compliance with regulatory standards
• Review and evaluate customer complaints for validity, processing, and necessary investigations
• Collaborate with cross-functional teams to address recurring quality issues and implement corrective actions

Required Qualifications

• 3-5 years of complaint handling experience in a GxP environment within the Pharmaceutical, Medical Device, or Biotech Industry
• Bachelor's degree or associate degree with 5 years of relevant experience
• Understanding of medical device regulations such as FDA 21 CFR and ISO 13485
• Hands-on experience with complaint management software and data analysis tools
• Demonstrated knowledge of compliance issues and risk management practices