GE HealthCare Medical Director Safety 

Remote, Remote 

350513567

Roles and Responsibilities

• Oversee and lead medical risk assessments and adverse event analysis in post market surveillance. 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 risk management and patient safety. 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 input into Research & Development, Quality & Regulatory Affairs and other functions within GEHC, as requested.

Required Qualifications

• Medical Degree with a specialty in Radiology or closely related field, preferably with board certification and a minimum of 2 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)

Desired Characteristics

• Knowledge base applicable to Ultrasound, Magnetic Resonance and Digital Health segments of the GE HealthCare organization. Significant product and domain knowledge of relevant radiologic healthcare technologies and current market trends.
• 2+ years’ experience in either the medical device industry or regulatory agency with strong knowledge of quality systems and relevant regulatory and risk management standards (e.g., FDA Quality Systems Regulations, ISO13485, ISO14971) is preferred, although candidates with a clear ability to gain the necessary knowledge will be considered.

Ourare designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

Application Deadline: September 05, 2024