General Electric Global Regulatory Leader - Development Products in Marlborough, Massachusetts
Job Description Summary
You will provide 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 in-depth knowledge of best practices and how own area integrates with others; has working knowledge of competition and the factors that differentiate them in the market
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.
Roles and Responsibilities
You will provide 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
Typically a 1st line manager of professionals or a 2nd line manager of a professional department. 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.
Bachelor’s degree in a scientific discipline; post-graduate degree preferred.
6+ years’ experience of global regulatory affairs from the pharmaceutical and/or healthcare industry with a track record in key strategic roles.
Experience of regulatory submissions and approvals in key regions such as EU, US and APAC, including new MAAs/NDAs.
Significant experience of global regulatory project management and world-wide regulatory authority interactions.
Experience of working with business leadership to define high level strategies.
Experience of working effectively across multinational/cultural environments.
May have skills and knowledge in specialized areas key to specific business need, for example registration of oncology/ immuno-oncology products or biologics.
Maintaining a keen interest in scientific advances that impact healthcare product development and regulation.
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.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer (https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.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 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).
As a federal government contractor, GE may in the future be required to have U.S. employees fully vaccinated against COVID-19. Some GE customers currently have vaccination mandates that may apply to GE employees.
Relocation Assistance Provided: No