What are the responsibilities and job description for the Complaint Manager position at React?
The Complaint Manager will focus on managing the complaint handling process and lead and manage the complaint handling team. This individual will participate in and coordinate investigations, update files, provide customer responses and ensure the complaint process is functioning in accordance with REACTHEALTH procedures. The Complaint Manager reports to the Director of Quality and Regulatory Compliance.
ROLE AND RESPONSIBILITIES:
- Develop, implement, and maintain Complaint and MDR procedures
- Participate in the complaint handling process as required
- Works cross functionally to ensure timely complaint closure
- Determine Medical Device Reporting in accordance with 21 CFR Part 803Medical 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
- Provide complaint trending and reporting for quality data reviews
- Identify and lead process improvements
- Participate in software validation of complaint handling systems
- Participate in external audits of the complaint process
- Perform otherduties as assigned
Salary : $49,200 - $62,300
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