Corrections and Removals Specialist IGT Systems

Be part of a fast-growing business that helps improve the lives of millions of people, while advancing Philips digital transformation journey as a global leader in Health Technology.

Being part of the correction and removal process will allow you working with cross functional teams to ensure that appropriate actions are taken on distributed products, ensuring patient safety, product quality and customer satisfaction.

With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.

Good working conditions

• Support the execution of post-market risk assessment (Issue Impact Assessment).
• Drive the preparation of Health Hazard Evaluation in cooperation with Product technical experts and Medical Affairs.
• Work in multifunctional teams contributing with Knowledge and experience to ensure proper preparation and execution of C&R, Risk Assessments, etc. often leading a cooperative effort among members of those teams.
• Drive the C&R strategy ensuring reportability decisions per Country and execution of activities according to the C&R strategy.
• Create all C&R related Customer Notifications and C&R Regulatory Submission reports (e.g. FSCA, 21CFR806).
• Manage the C&R file documentation and C&R file completion, ensuring that C&R records meet Good Documentation Practices.
• Support the preparation of responses to Regulatory agencies inquiries and provide follow up.
• Continuously track C&R execution and provide ongoing information to IGT Systems C&R management and teams as required.
• Act as a Quality and Regulatory expert for the C&R process.

To succeed in this role, you should have the following skills and experience

• BS in a Technical Discipline preferably in Healthcare, Engineering or Science.
• 6+ years of related experience 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 an 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). 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.
• Able to work in a changing environment and be a full supported of change.