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 Medical Director, Patient Safety is responsible for supporting strategies to ensure patient safety across assigned GE HealthCare modalities throughout the product lifecycle, focused on Ultrasound, Magnetic Resonance and Digital technologies. Reporting to the Chief Medical & Safety Officer, they will be responsible for supporting medical 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.

Job Description

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.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

Our total rewards are 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.

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For U.S. based positions only, the pay range for this position is $155,040.00-$232,560.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package,