JOB DESCRIPTION SUMMARY

At GE HealthCare our passionate people are creating the products, solutions and services our customers need to deliver the best patient care possible and to create a world where healthcare has no limits. The Senior Medical Director, Patient Safety is responsible for supporting strategies to ensure patient safety across assigned GE HealthCare modalities throughout the product lifecycle, focused on radiologic imaging technologies. Reporting to the Chief Medical & Safety Officer, they will be responsible for supporting medical safety and risk assessment processes from product development through post-market period.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

REQUIRED QUALIFICATIONS

• Medical Degree with post-graduate training in Radiology, preferably with board certification and a minimum of 3 years of post-training clinical experience.
• Strong problem solving, critical thinking and negotiation skills; ability to influence and make recommendations at multiple levels of the company; ability to participate and thrive in a dynamic environment that fosters transparency, collaboration and innovative thinking.
• Excellent verbal and written communication skills with the ability to communicate medical issues in English in an easy-to-understand manner.
• Prior experience working with Microsoft office products (Word, Excel, PowerPoint)

• Oversee and lead medical safety assessments supporting adverse event analysis in post-market surveillance system.
• Review and comment on risk assessment document for complaints; provide medical guidance to complaint handling teams regarding post-market safety assessments; sign off on reportability of Adverse Events; create white papers related to potential post market product issues as assigned by the CMSO.
• Participate in root cause analysis, preventive or corrective actions, and effectiveness monitoring.
• Participate on New Product Introduction teams for assigned modalities with a focus on patient safety and risk management.
• Provide pre-market design inputs from a medical and safety point of view; ensure safety and efficacy of protocols.
• Provide medical expertise to project teams on clinical testing of devices and implementation of clinical evaluations.
• Support and provide safety monitoring for assigned clinical trials as Medical Monitor. Review and approve clinical trial documentation within the duties noted in the appropriate standard operating procedures.
• Provide medical safety input into Quality & Regulatory Affairs, Research & Development, and other functions within GEHC, as requested.