Job description
The Complaint Specialist II will focus on the complaint handling process. This individual will input complaints into a database system, participate in and coordinate investigations, update files, provide customer responses and ensure timely closure of complaints. The complaint specialist reports to the Director of Quality and Regulatory Compliance, or designated Complaint Manager.
ROLE AND RESPONSIBILITIES:
- Receive and document complaints
- Follow up withinitial reporters for additional complaint information as required
- Perform and/or coordinate complaint investigations
- Works cross functionally to ensure timely complaint closure
- Determine Medical Device Reporting in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, and other international regulatory reporting
- Create and submit MDRs to regulatory agencies within required timeframes
- Maintain the complaint database
- Identify and lead process improvements
- Participate insoftware validation of complaint database
- Perform other quality and regulatory-related duties as assigned
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