Complaint Vigilance Director

Position Overview: The Complaint Vigilance Director will lead the strategic direction and ensure the success of the Complaint Handling, MDR, and post-market reporting programs. In this role, you will be responsible for managing the Vigilance Team. Responsible for team goal setting, performance assessments, and day-to-day people management. 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. 

Responsibilities:

• The primary interface to other department heads and upper management for complaint-related topics and trends.
• Execute complaint vigilance in conformance to current standards and procedures, using applicable system application tools in accordance with 21CFR820 / 21CFR803 and other regulations as required. 
• Oversee the triage assessment of complaints and assess initial risk and severity; Oversee the receipt, evaluation, investigation, and closure of complaints, including device malfunctions.
• Makes critical decisions for the Complaint Handling Unit (CHU).
• 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 the FDA.
• Ensure initial and follow-up reports are submitted to Regulatory Agencies within the 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.
• Conduct annual complaint training for all employees, including field sales, on the requirements to report complaints in a timely manner.

Requirements:

• Bachelor’s degree in science or engineering with 10+ years of experience or Master’s Degree with 7+ years’ experience in medical devices.
• Medical Device experience required.
• Extensive experience and deep working knowledge of complaint vigilance and MDR reporting. 
• Experienced in regulatory inspections and skilled in interacting with government officials.
• Experience with 21CFR820 / 21CFR803 and other regulations as required.
• Experience with post-market surveillance activities.

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