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Medical Safety Manager
3 maanden geleden
As the Medical Safety Manager, you will utilize your medical and clinical expertise to objectively assess safety risks and ensure the safety of Philip's medical devices throughout the product lifecycle. Your role will be focused within the Image Guided Therapy Systems (IGT-S) business.
Your work will directly influence product development, quality, and regulatory processes, ultimately contributing to the delivery of safe and high-quality patient care solutions.
Your role:
- The Medical Safety Manager is responsible for end-to-end clinical safety within the IGT Systems business. You will ensure that clinical safety assessments are key inputs into the product development, quality, and regulatory processes. A medically independent voice is key; however, collaboration in ensuring medical safety is expected.
- Provide objective medical safety and clinical input for the evaluation of potential safety issues for products in the field (IIA/HHE) including the assessment of clinical risks and hazards associated with the use of the medical device. Providing Medical Safety review and input into post-market deliverables such as Post-Market Surveillance Reports, Periodic Safety Update Reports, and Post-Market Clinical Follow-Up Reports.
- Assess adverse event trends, provide medical consultation for complaints, perform post-market risk assessments, and represent Medical Safety in Correction and Removal Board meetings.
- Provide Medical Safety review and input into post-market deliverables such as Post-Market Surveillance Reports, Periodic Safety Update Reports, and Post-Market Clinical Follow-Up Reports.
- Provide proactive clinical safety input for human factors formative and summative usability plans and reports, change request disposition, verification and validation, customer inquiries, regulatory and clinical compliance assessments, and competitor assessments.
- Demonstrate risk management knowledge and serve as a subject matter expert in the therapeutic area and patient risk management throughout the entire product lifecycle Stay informed and engaged with worldwide clinical practice guidelines, safety requirements, procedures, and expectations of global competent authorities.
- Provide objective medical safety and clinical input to product Safety Risk Assessment (SRA) or Risk Management Matrix (RMM) documents including severity, probability, and use case scenarios following evidence-based practice and use models. Incorporate internal and external input to ensure accurate and comprehensive SRA/RMM documents.
- Build clear, strong relationships between R&D; Quality, Regulatory, and other stakeholders to allow for a collaborative and compliant risk management system.
- Stay informed and engaged with our product portfolio and how it is used in the field, worldwide clinical practice guidelines, safety requirements, procedures, and expectations of global competent authorities.
- The Medical Safety Manager will collaborate with cross-functional teams in Europe and regions around the world, including R&D, Quality, Regulatory, and other stakeholders, to provide medical safety input throughout the product lifecycle. A key contribution is medical input for product risk management documents and processes.
You're the right fit if:
- You have a minimum of 5 years' experience in clinical direct patient care in a hospital environment and a focus in medical/clinical safety for end-to-end product lifecycle support, regulatory and clinical compliance/competitor assessments within FDA regulated medical device/technology environments (Patient/Cardiac Monitoring/Wearable Devices highly desired).
- You have detailed knowledge of Risk Management (ISO 14971), IIA and HHE's.
- You have proven experience in Post Market Surveillance (21CFR, MDD93/42/EEC and other global regulations), complaints and Corrections & Removals.
- You have a minimum of a Bachelor's Degree in a Scientific discipline or related field (Required). MS/MD/RN/APRN-desired
- You're able to effectively communicate, influence and build relationships with Internal/External Stakeholders at all levels.
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 improve the lives of others.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our employee benefits.
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.
