Clinical Practices/Protocols, Code of Federal Regulations, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Collection, Decision Support, Detail Oriented, Establish Priorities, FDA (Food and Drug Administration), Leadership, Maintain Compliance, Medical Coding, Medical Equipment, Patient Assessment, People Management, Performance Analysis, Performance Management, Performance Metrics, Performance Reviews, Problem Solving Skills, Process Improvement, Quality Management, Regulations, Regulatory Compliance, Regulatory Reports, Risk, Risk Management, Standard Operating Procedures (SOP), Time Management
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
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Katalyst Healthcares & Life Sciences