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.

Education and Experience Requirements  

• Bachelor's degree in life sciences, engineering, nursing, quality, regulatory affairs, or a related discipline. 

• Minimum of 8 years of progressive medical device experience, including substantial direct experience in complaint handling, post-market surveillance or related regulatory functions. 

• Minimum of 3 years of direct people leadership, preferably with responsibility for a complaint, post-market, vigilance, or regulatory organization. 

• Demonstrated experience making or overseeing complex reportability determinations and documenting and defending decisions during inspections, audits, or regulatory inquiries. 

• Demonstrated success improving complaint throughput, workload visibility, aging, backlog, process efficiency, or cross-functional investigation performance. 

• Expert working knowledge of FDA QMSR and ISO 13485, 21 CFR Parts 803 and 806, complaint handling, risk management, field actions and recalls, and applicable global vigilance requirements. 

Preferred Qualifications 

• Experience partnering with Legal, Product Liability, Risk Management, or outside counsel on adverse events, product claims, litigation, regulatory enforcement, or other sensitive post-market matters. 

• Experience with Class II or Class III medical devices and clinically complex adverse events. 

• Experience leading a complaint backlog remediation, operating-model redesign, or significant complaint-process transformation. 

• RAC, ASQ certification, an advanced degree, a JD, or other relevant legal education is desirable but not required.

Knowledge, Skills, and Abilities 

• Demonstrated ability to lead a supervisor and technical professionals while maintaining clear accountability across different levels of complaint work. 

• Ability to make timely, defensible reportability and escalation decisions when facts are incomplete or risk is uncertain. 

• Working knowledge of legal-risk, product-liability, confidentiality, documentation, and escalation considerations relevant to adverse events and complaint records. 

• Advanced analytical and problem-solving skills, including the ability to evaluate complaint trends, workload, capacity, aging, and root causes of delay or rework. 

• Ability to make risk-based decisions that give appropriate weight to regulatory obligations, patient safety, product quality, legal exposure, and business continuity. 

• Strong program and change-management skills, with demonstrated ability to stabilize operations while leading process and system improvements. 

• Excellent written and verbal communication skills, including concise documentation of reportability rationale, risk, decisions, and recommended actions. 

• Ability to influence senior leaders, regulatory agencies, auditors, legal partners, technical functions, and global business partners. 

• Proficiency with complaint management or electronic quality systems and advanced Excel or comparable data-analysis tools. 

• Ability to create and use practical dashboards and capacity models that drive daily prioritization, resource decisions, and sustained backlog reduction. 

• High level of integrity, sound judgment, professionalism, discretion, and confidentiality when handling sensitive patient, regulatory, employee, and legal information. 

Skill Requirements:

• Typing/Computer keyboard
• Utilize computer software (specified above)
• Retrieve and compile information
• Maintain records/logs
• Verify data and information 
• Organize and prioritize information/tasks 
• Operate office equipment 
• Verbal communication 
• Written communication 
• Research, analyze and interpret information 
• Investigate, evaluate, recommend action 
• Basic mathematical concepts (e.g. add, subtract) 

Physical Requirements:

• Sitting for extended periods
• Standing for extended periods
• Extended periods viewing computer screen
• Walking
• Reading
• Speaking
• Hear/Listen
• Maintain regular, punctual attendance
• Lifting/carrying up to 20 pounds various items
• Lifting/carrying more than 20 pounds various items
• Repetitive motions
• Pushing/Pulling
• Bending/Stooping
• Reaching/Grasping
• Writing

Hazards:

• Normal office environment