Correction and Removal Manager

Job Title

Job Description

Correction and Removal Manager

As a Corrections and Removals Manager, you will play a critical role in safeguarding patient safety, ensuring product quality, and maintaining customer trust. You will work closely with cross-functional teams to manage and execute C&R activities for distributed products, ensuring compliance with global regulatory requirements 

Your role: 

• Lead and coordinate the timely initiation and execution of Corrections and Removals (C&R) activities, collaborating with multifunctional teams to ensure regulatory and business requirements are met.
• Develop and manage all C&R-related customer notifications and regulatory submissions, including country-specific reportability decisions and required reports such as FSCA and 21 CFR 806.
• Maintain thorough and accurate C&R file documentation in alignment with Good Documentation Practices, ensuring compliance at every stage.
• Work closely with cross-functional teams to develop and implement technical solutions on schedule, proactively escalating reportable situations to authorities or customers as needed.
• Drive operational excellence within the C&R team by maintaining up-to-date trackers, supporting continuous improvement initiatives, and preparing timely responses and documentation for management reviews and regulatory inquiries.

You're the right fit if: 

• You've acquired 3+ years of experience combined in a medical device or regulated industry in Correction and Removals, risk management, or design quality processes and/or project management or structured research experience in related areas.

• Your skills include strong knowledge of quality management systems and regulatory requirements (21 CFR part 806, EU MDR, etc.); excellent analytical and process improvement capabilities, ability to manage multiple projects and priorities effectively, and a proven ability to embrace and drive change. Knowledge of Philips IGT Systems and Product knowledge is strongly preferred.

• You have a bachelor's degree or higher in a technical discipline (Healthcare, Engineering, or Science). Master’s or PhD in a healthcare related area strongly preferred.

• You're an excellent communicator (written and verbal in English), with a strong ability to convey technical content to diverse audiences (authorities, customers, internal teams); possess a high degree of initiative, engagement, and flexibility in a dynamic environment, and strong learning ability to adapt to changing requirements.

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 role is office-based.

About Philips 

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. 

• Learn more about our business here. 
• Discover our rich and exciting history here. 
• Learn more about our purpose here. 

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.