Director, Correction & Removal Operations
This role is for a Director, Correction & Removal Operations.
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.
Your role:
- 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're the right fit if:
- 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 English, with other languages being a plus.
You are willing to travel globally up to 25% to support operational alignment, field action and audit readiness.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
How we work together:
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an office-based role.
About Philips:
We are a health technology company.