Job description:
• Lead, manage, and develop a team of 20-25 employees across screening, investigation, and MDR submission functions
• Establish clear roles, responsibilities, and performance expectations
• Set and monitor daily and weekly output targets aligned to remediation timelines
• Conduct routine performance assessments, including throughput, accuracy, and rework trends
• Provide targeted, real-time feedback to drive quality and efficiency
• Oversee end-to-end MDR remediation workflow, including:
Reportability assessment
Investigation and data gathering
MDR preparation and submission
• Ensure adherence to standardized workflows, including a structured 4-phase remediation model
• Ensure all MDR decisions align with:
o 21 CFR Part 803 o SOP-00048
o FDA reportability guidance
• Review outputs for accuracy, completeness, and consistency with risk files and established criteria
• Enforce standardized language justification for reportability decisions
• Implement and maintain standardized processes, templates, and tools
• Ensure consistent use of malfunction matrices and MDR numbering conventions
• Serve as escalation point for complex or ambiguous cases
• Partner with Clinical, Regulatory, and Quality teams to resolve issues and support decision making
• Track and report key performance metrics, including throughput, timeliness, and quality trends
• Provide regular updates on remediation progress, risks, and resource needs
• Support audit readiness, CAPA effectiveness monitoring, and FDA inspection activities
• Ensure team training completion, role qualification, and adherence to regulatory standards
Basic Qualifications
• Bachelor's degree in a scientific, engineering, or related field
• Minimum of 5 years of experience in medical device complaint handling, MDR reporting, or regulatory compliance
• Minimum of 2 years of direct people management experience
• Strong knowledge of 21 CFR Part 803 and MDR requirements
• Experience with complaint handling systems (e.g., ETQ Reliance, Track Wise)
• Experience supporting FDA inspections and CAPA activities
Preferred Qualifications
• Experience leading MDR remediation or retrospective review programs
• Familiarity with FDA eMDR submission processes
• Experience with FDA device, patient, and evaluation coding
• Knowledge of risk management and CAPA integration
• Experience building or optimizing high-volume workflows
Core Competencies
• Leadership and performance management
• Audit readiness and attention to detail
• Regulatory decision-making in complex scenarios
• Process improvement and standardization
• Cross-functional communication and collaboration
Work Environment / Expectations
• Fast-paced, high-volume regulatory remediation environment
• Requires strong prioritization, organization, and decision-making skills
• Ability to manage multiple workstreams and deadlines simultaneously
