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