Clinical Risk Manager
2 maanden geleden
About the Role:
The Medical Safety Manager will play a critical role in ensuring the safety of Philips' medical devices throughout the product lifecycle. This position will be focused within the Image Guided Therapy Systems (IGT-S) business.
Key Responsibilities:
- Provide objective medical safety and clinical input for the evaluation of potential safety issues for products in the field, including the assessment of clinical risks and hazards associated with the use of the medical device.
- 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.
- 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.
Requirements:
- A minimum of a University Degree in a scientific discipline or related field (Medical Degree, Medicine, Physician).
- A minimum of 3 years' experience in clinical direct patient care in a hospital environment (Patient/Cardiac Monitoring/Wearable Devices is highly desired).
- Effective communication, influence, and relationship-building skills with Internal/External Stakeholders at all levels.
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