Medical Safety Expert
2 maanden geleden
About the Role:
We are seeking a highly skilled Medical Safety Manager to join our team at Philips. As a Medical Safety Manager, you will play a critical role in ensuring the safety of our medical devices throughout the product lifecycle.
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 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.
- Stay informed and engaged with worldwide clinical practice guidelines, safety requirements, procedures, and expectations of global competent authorities.
- Build clear, strong relationships between R&D, Quality, Regulatory, and other stakeholders to allow for a collaborative and compliant risk management system.
Requirements:
- University Degree in a scientific discipline or related field (Medical Degree, Medicine, Physician).
- Minimum of 3 years' experience in clinical direct patient care in a hospital environment (Patient/Cardiac Monitoring/Wearable Devices is highly desired).
- Ability to effectively communicate, influence, and build relationships with Internal/External Stakeholders at all levels.
About Philips:
We are a health technology company dedicated to improving the lives of patients and healthcare professionals around the world. Our mission is to make a meaningful difference in the lives of people by delivering innovative solutions that improve healthcare outcomes.
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