Medical Safety Manager

2 maanden geleden

Best, Nederland Philips Voltijd

JOB DESCRIPTION

Job Title

Job Description

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 a University Degree in a scientific discipline or related field, MS/MD/RN/APRN is desired

You have a minimum of 5 years' experience in either a clinical direct patient care in a hospital environment (Patient/Cardiac Monitoring/Wearable Devices highly desired)

OR you have 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, knowlegde of Risk Management (ISO 14971), IIA and HHE’s and proven experience in Post Market Surveillance (21CFR, MDD93/42/EEC and other global regulations), complaints and Corrections & Removals.

You are able to effectively communicate, influence and build relationships with internal and 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.

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Medical Safety Manager