Philips Medical Safety Manager 

Netherlands, North Brabant 

593902952

As a Medical Safety Manager, you will leverage your medical expertise to ensure and improve the safety of our medical devices. Your role will be focused within the Image Guided Therapy Systems (IGT-S) business. This business specializes in interventional X-ray systems that provide real-time imaging to guide physicians during diagnostic, interventional, and minimally invasive procedures. Interventional X-ray systems are also known by other terms such as mobile or fixed C-arms, cathlabs, angiography systems, or interventional radiology suites.

Positioned within the medical affairs department, the role supports in maintaining systems for ongoing safety surveillance of medical products, including post-market surveillance studies, literature reviews, and monitoring of real-world data to identify potential safety issues or emerging risks. The role prioritizes patient well-being throughout the product lifecycle, from initial development stages to post-market surveillance, to ensure optimal safety outcomes and compliance with regulatory standards.

In your role, amongst others, you will:

• work in a diverse, dynamic, and cross-functional environment, collaborating closely with medical affairs and stakeholders from R&D, Quality, and Regulatory.
• be part of the Medical Safety team, which holds end-to-end responsibility for medical safety within the IGT Systems business. As a medical subject matter expert you will provide essential support in bolstering patient safety by actively contributing insights and recommendations to critical processes such as Risk Management, Health Hazard Evaluations (HHE), Risk-Benefit analyses, and recall procedures.
• conduct comprehensive evaluations of safety information sourced from a variety of channels such as Post- Marketing Surveillance and literature searches, working under limited supervision.
• offer valuable assistance in delivering safety-related perspectives for New Product Introduction projects, clinical studies, and Post-Marketing Surveillance efforts, facilitating informed decision-making.
• provide answers to safety-related inquiries from healthcare professionals, patients, and internal stakeholders, fostering trust and transparency in communication regarding product safety.
• collaborate effectively to furnish pertinent safety inputs for regulatory submissions and key documents ensuring compliance and transparency in safety evaluations.
• contribute to the implementation of safety-related policies, procedures, and programs to promote a culture of safety and compliance within the organization

You're the right fit if:

• You hold a Medical Degree (M.D., Doctor of Medicine) (preferred) or related healthcare- degree that emphasizes patient care.
• You have clinical experience with interventional X-ray systems (preferred), or related clinical experience in a clinical domain where interventional X-ray systems are used (e.g., interventional cardiology/neurology)
• Minimum 3 years of experience with Master's in areas such as in Medicine, and/or Medical/Clinical affairs in Medical Device/Biotech industry or equivalent
• You are a team player. You excel at positively and effectively communicating, influencing, and building relationships with stakeholders at all levels.
• You possess strong problem-solving and analytical thinking skills, and you combine these with effective good documentation practices (GDP).
• You possess an understanding of stringent regulations governing the medical device industry (e.g., FDA, EUMDR, ISO standards)

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