Manager, Regulatory Affairs MR

Job Description Summary

This position provides regulatory strategy and direction to the Premium Segment of the Magnetic Resonance Imaging business regarding healthcare industry regulatory requirements for product launch premarket submissions / registrations and postmarket compliance working closely with healthcare regulatory bodies globally.

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.
• Manages a team of Regulatory Affairs professionals as well as an individual contributor.
• Developing specialized depth and / or breadth of expertise in own job discipline or field. Serves as best practice / quality resource. Has awareness of latest functional developments in own area. Contributes towards strategy and policy development and ensures delivery within area of responsibility.
• Skilled influencer able to communicate complex messages to others. Acts as a resource for colleagues with less experience. May lead small projects with moderate risks and resource requirements. Explains difficult or sensitive information; works to build consensus. Developing persuasion skills required to influence others on topics within field.
• Impacts approaches projects and programs in the functional area or affected business organization and ways of working. Impacts quality efficiency and effectiveness of own team. These jobs have significant input into their priorities. Jobs at this level tend to be covered by professional practices and policies but these are shaped by the role. Working within broad guidelines and policies roles at this level have moderate autonomy requiring high levels of evaluative judgment.
• Uses judgment to make decisions or solve moderately complex tasks or problems that impact the function. Takes new perspective on existing solutions. Uses technical experience and expertise for data analysis to support recommendations. Uses multiple internal and limited external sources outside of own function to arrive at decisions.

Required Qualifications

Desired Characteristics

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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.

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 : Yes

Required Experience :

Manager

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1