MDR Supervisor

We’re hiring a Supervisor, MDR Remediation to lead a high-volume team supporting retrospective Medical Device Reporting (MDR) activities in response to FDA 483 observations. This role will manage 20–25 team members across screening, investigation, and MDR submission activities, ensuring work is completed accurately, consistently, and on time in an audit-ready manner. What you’ll do Lead, coach, and manage a team of 20–25 across MDR screening, investigation/data gathering, and MDR preparation/submission Set daily/weekly productivity targets and monitor throughput, quality, and rework trends Provide real-time feedback and performance management to drive speed and accuracy Oversee end-to-end MDR remediation workflow, including: Reportability assessment Investigation and data gathering MDR preparation and submission Ensure decisions align with 21 CFR Part 803, internal SOPs, and FDA reportability guidance Standardize decision-making and documentation (templates, language justification, tools, numbering conventions) Serve as escalation point for complex/ambiguous cases and partner with Clinical/Regulatory/Quality stakeholders Track/report progress, risks, and metrics; support audit readiness and inspection support activities Ensure training completion and role qualification for all team members Required qualifications Bachelor’s degree in a scientific, engineering, or related field 5+ years in medical device complaint handling, MDR reporting, or regulatory compliance 2+ years of direct people management experience Strong working knowledge of 21 CFR Part 803 and MDR requirements Experience with complaint handling systems (e.g., ETQ Reliance, TrackWise) Experience supporting FDA inspections and/or CAPA activities Preferred qualifications Experience leading MDR remediation / retrospective review programs Familiarity with FDA eMDR submission processes Experience with FDA device/patient/evaluation coding Risk management and CAPA integration exposure Background building or optimizing high-volume workflows #J-18808-Ljbffr Dexian