Intuvie

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 complaint management procedures are optimized and that the vigilance team responds to and resolves complaints within a timely fashion while conforming to appropriate standards and procedures.

ESSENTIAL JOB FUNCTIONS

• Execute complaint vigilance in conformance to current standards and procedures, using applicable system application tools in accordance with 21CFR820, 21CFR803, ISO 13485, and other regulations as required.
• Oversee the initial assessment of complaints and assess risk and severity in accordance with product risk management files.
• Oversee the receipt, evaluation, investigation, and closure of complaints, including device malfunctions.
• Work with product/manufacturing/research & development/quality/medical affairs teams to ensure timely, accurate and complete investigations of product complaints and timely closures.
• Prepare reports with analysis 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.
• Track and report metrics on process timeliness and effectiveness.
• Represent the complaint handling unit in FDA inspections.

OTHER DUTIES AND RESPONSIBILITIESPREPARATION, KNOWLEDGE, SKILLS & ABILITIES

• Bachelor’s degree in science or engineering with 10+ years of experience or Master’s degree with 7+ years of experience in medical device. Extensive experience and deep working knowledge of complaint vigilance and MDR reporting.
• Experienced in regulatory inspections and skilled in interacting with government officials.
• The Complaints Vigilance Director is responsible for managing the Vigilance Team. Responsible for team goal setting and performance assessments, as well as day-to-day people management.