
Medical Safety Manager, Enterprise Informatics
Are you passionate about improving healthcare through the use of technology? Do you have experience in ensuring the safety and compliance of medical systems? Then we have an exciting opportunity for you! Philips is seeking a highly skilled and motivated Medical Safety Manager for our Enterprise Informatics division. In this role, you will be responsible for overseeing the safety and risk management of our medical software systems, playing a crucial role in the development and maintenance of safe and effective products. We are looking for a detail-oriented individual with a strong background in medical device regulations and risk management. Join our team and make a difference in the lives of patients worldwide!
- Develop and maintain a thorough understanding of medical device regulations, including FDA and international standards, related to software safety and risk management.
- Collaborate with cross-functional teams to ensure compliance with all applicable regulations and industry standards.
- Conduct risk assessments and identify potential hazards and risks associated with medical software products.
- Develop and implement risk management strategies and plans to minimize potential risks and ensure product safety.
- Review and assess software design and development processes to ensure compliance with safety regulations and standards.
- Communicate with regulatory agencies and notified bodies regarding safety and risk management activities for medical software products.
- Stay updated on industry trends and changes in regulations related to medical software safety and risk management.
- Train and educate team members on safety and risk management processes and procedures.
- Lead and participate in safety-related meetings and forums to discuss and resolve potential safety issues.
- Collaborate with product development teams to ensure safety requirements are incorporated into the design and development process.
- Conduct post-market surveillance activities and monitor safety-related complaints and incidents.
- Provide guidance and support to product teams on safety and risk management issues.
- May participate in audits and inspections related to medical software safety and risk management.
- Continuously identify and implement improvements to enhance the safety and compliance of medical software products.
- Act as a subject matter expert on medical software safety and risk management for the company.
Bachelor's Or Master's Degree In Health Informatics, Healthcare Administration, Or A Related Field.
Minimum Of 5 Years Of Experience In A Healthcare Setting, Preferably In A Leadership Role.
Knowledge Of Medical Device Regulations And Standards, Such As Iso 13485 And Fda Guidelines.
Experience With Implementing And Managing Enterprise Informatics Systems, Including Electronic Health Records And Clinical Decision Support Tools.
Strong Communication And Interpersonal Skills, With The Ability To Collaborate With Various Stakeholders And Departments To Ensure Compliance And Safety Standards Are Met.
Risk Management
Quality Assurance
Change Management
Project Management
Data Analysis
Incident investigation
Regulatory compliance
Training Development
Emergency Response
System integration
Safety Protocols
Compliance Auditing
Communication
Conflict Resolution
Customer Service
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Medical Safety Manager, Enterprise Informatics in Nashville, TN, USA is $92,000 to $130,000 per year. This can vary depending on factors such as years of experience, education, and specific job responsibilities.
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Royal Philips is a health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. The company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care.

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