Manager, Complaint Management & Post-Market Compliance (34929)

Job Summary

The Manager, Complaint Management and Post-Market Compliance provides strategic, regulatory, and operational leadership for complaint management, post-market surveillance, adverse event reporting, and field action and recall activities. The role leads the Quality Management Complaint Supervisor and Quality Management, Complaint Specialists and ensures that intake, file progression, reportability assessment, investigation, escalation, and closure are controlled, timely, and compliant with applicable global requirements.

The Manager serves as the subject matter expert for complex complaints and post-market matters involving patient safety, significant regulatory exposure, potential product liability, or legal risk. The Manager is accountable for complaint strategy, inspection readiness, workload and capacity visibility, sustained backlog reduction, process simplification, and development of the complaint organization. The role exercises independent judgment in regulatory reportability, patient and product risk, resource allocation, and escalation of sensitive complaint matters.

Essential Functions, Duties, and responsibilities

Strategic & Operational Leadership

• Provide strategic leadership and governance for complaint management, post-market surveillance, Medical Device Reporting (MDR), global vigilance, and field action and recall activities.

• Establish complaint objectives, performance measures, organizational structure, service expectations, and resource plans aligned with business and quality priorities.

• Advise Quality and Regulatory leadership on complaint risk, reportability, emerging trends, field action considerations, resource needs, and remediation priorities.

• Establish transparent measures for workload, capacity, aging, throughput, reportability timeliness, investigation status, returns, and backlog by work type and owner.

• Use complaint data and trend analysis to identify emerging safety, quality, regulatory, and operational risks and initiate appropriate escalation or action.

Quality Systems and Regulatory Compliance

• Ensure compliance with the FDA Quality Management System Regulation (QMSR), 21 CFR Part 820 incorporating ISO 13485, 21 CFR Parts 803 and 806, MDSAP requirements, and applicable global vigilance requirements.

• Own the complaint process from intake through closure, including timely evaluation, investigation coordination, reportability assessment, escalation, documentation, and approval.

• Provide expert oversight of complex adverse event and reportability assessments, including events involving death, serious injury, malfunction, incomplete information, or potential recurrence.

• Direct complaint-related evaluations for corrections, removals, field actions, recalls, and product advisories, and coordinate required regulatory notifications and leadership decisions.

• Ensure complaint records, investigations, reportability decisions, submissions, and related documentation are factually consistent, scientifically supportable, traceable, and inspection-ready.

• Lead complaint-related responses to FDA inspections, notified body and MDSAP audits, regulatory inquiries, audit findings, and remediation commitments.

Legal and Cross-Functional Collaboration

• Partner with cross-functional teams on complex or sensitive complaint matters.

• Coordinate with Legal on patient inquiries, potential claims, litigation, regulatory enforcement matters, information requests, and preservation or confidentiality needs, as applicable, without serving as legal counsel.

• Serve as the complaint and post-market representative for management reviews, escalation forums, health hazard or field action evaluations, and cross-functional risk assessments.

• Establish clear responsibilities, service expectations, and escalation paths with investigation owners and global quality and regulatory partners to reduce delays and rework.

People Leadership and Development

• Lead, coach, and develop the Quality Management Complaint Supervisor and Quality Management Complaint Specialists and build the judgment, technical depth, and operational discipline required for a high-performing complaint organization.

• Set measurable expectations for quality, timeliness, workload control, backlog reduction, proactive problem solving, and cross-functional follow-through.

• Create development and succession plans that support progression from Coordinator to

• Communicate priorities, risks, decisions, and performance clearly to employees, cross-functional partners, and senior leadership.