Correction and Removal Manager
4 maanden geleden
**Job Title**: Correction and Removal Manager
Be part of a fast-growing business that helps improve the lives of millions of people, while advancing Philips's digital transformation journey as a global leader in Health Technology.
**Your role**:
As a part of the correction and removal process, you will be collaborating with cross-functional teams to guarantee that necessary steps are taken regarding distributed products, prioritizing patient safety, product quality, and customer satisfaction.
- Ensure effective Correction & Removals (C&R) processes are in place, coordinating various contributors and guiding strategy to meet stakeholder expectations.
- Lead document creation, manage files, and support regulatory inquiries.
- Monitor activities, track metrics, and drive continuous improvement efforts.
- Support the preparation of responses to Regulatory agencies'' inquiries and provide follow-up.
- Create all C&R - related Customer Notifications and C&R Regulatory Submission reports (e.g. FSCA, 21CFR806, monthly status reports).
- Act as a Quality and Regulatory expert for the C&R process.
**You're the right fit if**:
- BS in a Technical Discipline preferably in Healthcare, Engineering or Science.
- 6+ years of related experience as well as education in a medical device or regulated industry preferably in Correction and Removal processes, regulatory submission, Risk Management
- Project Management skills. 2+ yeas of project management is a large advantage.
- In-depth knowledge of Quality management systems and deep understanding of related regulation (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).
- Good analytical skills and process improvement capabilities.
- Strong written and oral communication skills in English and demonstrated ability to effectively communicate technical content to a variety of internal and external audiences (e.g. Authorities, customers).
**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.
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