Director, Correction & Removal Operations

Director, Correction & Removal Operations Job Description

The Director of Correction & Removal Operations is responsible for the coordinated, timely and compliant execution of all global medical device Corrections & Removals (C&R). This leader drives operational excellence and serves as the central hub for cross-functional execution activities.

• Lead global execution of all C&R activities, ensuring timely implementation, documentation, and closure of field actions across all regions.
• Responsible for Strategic/Functional team leadership, employee selection, performance management, career development, setting clear goals/KPI’s, open communication, and cultivating a positive/motivating work environment to foster engagement.
• Translate C&R strategic frameworks into actionable operational plans, including detailed workflows, timelines, resource allocation, and country-specific requirements, while driving simplification and efficiency to reduce complexity and accelerate execution.
• Oversee cross-functional coordination among Regulatory Affairs, Supply Chain, Customer Service, Quality Systems, Field Service, Manufacturing, and distribution centers to ensure seamless execution.
• Ensure global regulatory compliance by preparing, coordinating and/or supporting necessary notifications submissions, and follow-up reports to competent authorities. Ensure consistent communication with internal stakeholders and external customers, working with Customer Service and Marketing to deliver clear, accurate, and timely external communications during field actions.
• Manage operational readiness and response, ensuring the organization can rapidly activate C&R processes for emerging issues.
• Support and guide regional C&R strategy and operations teams, ensuring consistent application of global procedures and timely status reporting. Support audits and inspections, ensuring C&R files, processes and documentation demonstrate compliance with global regulatory expectations.
• Maintain accurate and compliant documentation, including action plans, traceability records, verification and validation evidence, and closure summaries.
• Monitor and report operational performance, including execution timelines, product retrieval rates, completion status, customer communication effectiveness, and regional performance.
• Identify and drive operational improvements, including process standardization, automation opportunities, and reduction of cycle time for field actions.
• Partner closely with the Global C&R Capability & Strategy leader to provide operational insights, execution feedback, and recommendations for strengthening strategy and frameworks.

• You have a minimum of 10+ years’ experience in regulated medical device environments, with proven expertise in post market surveillance, corrections & removals, field actions and quality operations.
• You have a minimum of 4+ years as a functional/strategic leader, including mentoring, training, succession planning, hiring, performance management, and technical/professional development of team members.
• You have a deep understanding of global C&R regulatory requirements (FDA 21 CFR 806/7, EU MDR, Health Canada, APAC regulations, etc.) and ISO standards (9001, 13485, 14971).
• You have strong operational leadership skills, including the ability to coordinate complex, multi-region activities and overseeing cross-functional teams and driving alignment across Supply Chain, Regulatory Affairs, Quality Systems, Customer Support and Field Service.
• You’re able to collaborate effectively with global teams across different time zones, cultures, and remote working environments
• You have a process-driven mindset, with proven success in standardizing workflows and eliminating operational variability.
• You have strong skills in data integrity, documentation quality, traceability requirements, and audit readiness.
• You have a track record of continuous improvement, including cycle-time reduction, operational efficiency, or KPI improvements.
• You have a minimum of a Bachelor’s degree in Quality, Engineering or a related discipline (required). ASQ certifications (desired).
• You have full proficiency in…