Complaint Handling Specialist

Job Summary

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

Key Responsibilities

• Conduct complaint handling activities and manage the end-to-end process of customer complaints
• Review customer complaints for validity and ensure compliance with policies and procedures
• Perform complaint risk assessments and provide input for continuous improvement of the complaint handling process

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 combined with 5 years of relevant experience
• Understanding of medical device regulations (FDA 21 CFR and ISO standards)
• Hands-on experience with complaint management software and data analysis tools
• Demonstrated knowledge of compliance issues and risk management