Compliance Specialist

Job Summary

A company is looking for a Compliance Specialist to manage the complaint determination process in compliance with established regulations.

Key Responsibilities

• Review and execute the process to determine if an inquiry record qualifies as a medical device complaint
• Assign cases categorized as complaints and non-complaint feedback for effective handling and reporting
• Reassess inquiry records upon receipt of new information and perform additional complaint handling tasks as needed

Required Qualifications

• Experience in medical device complaint handling or a related field preferred
• Solid understanding of QSR and/or ISO 13485 preferred
• Demonstrated knowledge of Microsoft Office
• Working knowledge of complaint handling functions in a medical device company preferred
• Familiarity with TrackWise and SalesForce CRM preferred