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Medical Safety Manager
1 maand geleden
**Job Title**: Medical Safety Manager
As the 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 mínimally 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 medical safety team is responsible for providing independent, objective, and unbiased assessments of potential and actual safety risks throughout the product lifecycle. Your work will directly influence product development, thereby contributing to the delivery of safe and high-quality patient care solutions.
**Your role**:
- New product development: you will ensure that new products are clinically relevant, meaningful, and safe for patients and users
- Post market surveillance: you will support post-market surveillance activities (e.g., post-market surveillance reports) with a primary focus on medical safety aspects.
- Safety concerns: Provide objective medical safety input during the evaluation and resolution of potential safety issues with products already in the field
- In your role, in collaboration with the medical affairs team, you will stay informed and engaged with global clinical practice guidelines, current clinical standards, safety requirements, and clinical procedures related to the use of interventional X-ray systems.
- In your role, you will leverage your clinical problem-solving skills and analytical capabilities to provide independent, evidence-based medical input. This will involve evaluating clinical risks, building scenarios, and explaining trade-offs to make well-informed risk-benefit determinations.
- In your role, you will work in a diverse, dynamic, and cross-functional environment, collaborating closely with medical affairs as well as teams from R&D, Quality, and Regulatory.
- The medical device industry is highly regulated by healthcare authorities and industry standards. In your role, you will contribute to & ensure compliance with these regulations guaranteeing the highest level of patient safety and product quality.
- In your role you can expect to oversee & contribute to risk management activities, focusing on medical safety, ensuring compliance with regulations and to maintain the highest standards of patient safety and product quality.
**You're the right fit if**:
- You hold a Medical Degree (M.D.) (preferred) or another healthcare-related university degree with a strong focus on patient care, such as an MSc in Technical Medicine
- You have clinical experience with interventional X-ray systems (preferred), or relevant clinical experience in a therapeutic domain where interventional X-ray systems are used
- You are a team player who excels at effectively communicating, influencing, and building relationships with stakeholders at all levels.
- You possess strong problem-solving and analytical thinking skills to provide evidence-based medical evaluations of clinical risks and benefits
- You possess an understanding of stringent regulations governing the medical device industry (e.g., FDA, EUMDR, ISO standards)
**About Philips**
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