Job Description Summary

　　Provides regulatory strategy and direction to the Magnetic Resonance business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. This position will be supporting the Magnetic Resonance Coils and 3.0T segments. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how the work of own team integrates with other teams and contributes to the area.

　　This role is Hybrid.

　　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:

　　Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally

　　Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.

　　A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.

　　Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance.

　　Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

　　Required Qualifications:

　　Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of relevant work experience) with 3 years of relevant experience in medical device regulatory affairs OR MR Engineering experience OR Imaging Engineering experience.

　　Ability to drive problem solving with good negotiation skills

　　Desired Characteristics:

　　Advanced degree in scientific, technology or legal disciplines

　　Regulatory Affairs Certification (RAPS)

　　Team-oriented and responsive to customer needs.

　　Ability to understand technical documentation and execute associated procedures.

　　Ability to understand the healthcare environment, the competitive, commercial and political environment, and their impacts on the regulatory strategies

　　Experience with the development of medical devices from an engineering, quality or regulatory perspective is preferred.

　　Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs.

　　Established project management skills.

　　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.

　　While GE does not currently require U.S. employees to be vaccinated against COVID-19, some GE customers have vaccination mandates that may apply to certain GE employees. Please note as a federal government contractor, GE may in the future be required to have U.S. employees fully vaccinated against COVID-19.

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　　Additional Job Description

　　Additional Information

　　Compensation Grade

　　LPB2

　　GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunities Employer. (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf) Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

　　GE HealthCare will only employ those who are legally authorized to work in the United States for this opening.

　　While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

　　Relocation Assistance Provided: Yes