Complaint Vigilance Director - Natick, United States - Intuvie
3 weeks ago
Description
Position Title:
Complaint Vigilance Director
Reports To:
VP of Quality Assurance
GENERAL SUMMARY
Sets strategic direction and ensures success of the Complaint Handling, MDR and post market reporting programs. Makes critical decisions for the Complaint Handling Unit (CHU). Primary interface to other department heads and upper management for complaint related topics and trending.
Ensures complaints management procedures are optimized and that the vigilance team responds to and resolves complaints within a timely fashion while conforming to the correct standards and procedures.
ESSENTIAL JOB FUNCTIONS
- Oversee the triage assessment of complaints and assess initial risk and severity; Oversee the receipt, evaluation, investigation, and closure of complaints, including device malfunctions.
- Work with all product/manufacturing/research & development/quality teams to ensure timely, accurate and complete investigations of product complaints and timely closures.
- Review reports of complaint trends
- Oversee the assessment of complaints for MDR reportability to FDA
- Ensure initial and follow up reports are submitted to Regulatory Agencies within required timelines.
- Ensure complaints are classified correctly and that all supporting data are adequately documented and attached to the complaint file.
- Ensure procedures meet current and evolving requirements.
- Review metrics on process timeliness and effectiveness.
- Oversee post market surveillance activities
- Review and approve Complaint Vigilance Reports (i.e. quarterly trending, monthly, complaint records) in a timely manner
OTHER DUTIES AND RESPONSIBILITIES
- Conduct annual complaint training for all employees including field sales on the requirements to report complaints in a timely manner
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