Job title:
Corrections and Removals Specialist
Your role:
Supports the preparation of C&R documents for Mobile Systems.
Works with different stakeholders in the Business and Markets (e.g. service, R&D) to support timely execution of C&R.
Keeps oversight of IGT System C&R KPIs and metrics supporting development of corrective action plans as applicable.
Monitors implementation and documentation of technical solutions related to C&R, including verification of service records quality
Monitors submission by Markets C&R, confirms completeness of records received, and ensures archiving of records in IGT Systems.
Monitors timely responses to requests from Competent Authorities and Notified Bodies on Corrections and Removals.
Responsible for maintaining the C&R archive for Q&R records, including managing the review and approval flow.
Supports timely termination of C&R with the FDA and other Regulatory Authorities by proactively monitoring the completion of C&R activities.
Supports timely preparation of KPIs and Daily Management information.
Prepares C&R Reports for Management and different stakeholders (weekly/monthly/central)
You're the right fit if: (4 x bullets max)
1. Experience- 6+yrs of industry experience (Prefer medical devices exp)
2. Skills-
Supports the preparation of C&R documents for Mobile Systems.
Works with different stakeholders in the Business and Markets (e.g. service, R&D) to support timely execution of C&R.
3. Education- Bachelor's degree
4. Anything else-
Knowledge of Quality management systems and related regulation is and advantage (e.g. 21 CFR Parts 803, 806, and 820, EU MDR – Regulation (EU) 2017/745, ISO 13485, ISO 14971, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169). Proven work experience is preferable.
Good analytical skills and process improvement capabilities.
Strong written and oral communications skills in English and demonstrated ability to effectively communicate technical content to a variety of internal and external audiences (e.g. Authorities, customers).
Ability to successfully balance and prioritize multiple ongoing projects/tasks.
Strong attention to detail and accuracy.
High reliability and quality focus.
High degree of initiative, engagement, self-motivation and flexibility.
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.
Indicate if this role is an office/field/onsite role.
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.
• Discover our rich and exciting history.
• Learn more about our purpose.
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.
Works with different stakeholders in the Business and Markets (e.g. service, R&D) to support timely execution of C&R.
