Quality Manager 3 - Regulatory Affairs
Quality Manager 3 - Regulatory Affairs
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Job Description
Job Description Summary
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch premarket submissions/registrations and postmarket compliance working closely with healthcare regulatory bodies globally. Has indepth knowledge of best practices and how own area integrates with others; has working knowledge of competition and the factors that differentiate them in the marketGE 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 worldchanging 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 CT business and ISS business regarding regulatory requirements for product launch premarket submissions/registrations and post market compliance working closely with healthcare regulatory bodies globally. Drives 510k NMPA and MDR strategies and work with cross functional team to execute submission plans.
Develops specialized depth and/or breadth of expertise in medical imaging devices with a focus on CT imaging. Has keen awareness of latest regulatory developments for the medical devices in the US and globally. 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 regulatory experience or other functions that may not have in depth regulatory experience or knowledge. Provides guidance to NPI teams on regulatory strategy impact assessment and of regulatory plan. Explains difficult or sensitive information; works to build consensus. Developing persuasion skills required to influence others on topics within field. This role also contribute significantly to internal and external audits.
Impacts quality efficiency and effectiveness of own team. These jobs have significant input into business priorities. 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
BS/BE in a STEM field plus 7 years experience in medical device quality or regulatory field or MS degree in a STEM field
5 years experience in medical device quality or regulatory field. Has hands on 510k NMPA and MDD (or MDR) experience as well as global submission experience
A total of 15 years of experience
Desired Characteristics
Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects. Ability to document plan market and execute programs. Established project management skills.
Experience in 510k and NMPA submissions for SaMD or AI technology a plus.
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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.
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 worldchanging 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
Additional Information
Relocation Assistance Provided: No
Required Experience:
Manager
Employment Type
Full-Time
