Medical Safety Manager

• 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 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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Philips