Quality Lead Specialist - Regulatory Affairs

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 Premium segment. 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 can be a hybrid role, both on-site and remote when it makes sense.

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 MR 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

• Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

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.

#LI-MC2

#LI-Hybrid

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. 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. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

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: No