General Electric Regulatory Affairs Leader in Lynn, Massachusetts
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 knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market
Roles and Responsibilities
GEHC ONLY - 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
Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.
The role has the option to be located remotely.
Bachelor's Degree in Chemical, Electrical Engineering or In Legal.
Minimum of 2 years experience working in a regulated industry
Ability to identify deliverables, to prioritize and plan them to meet strategic goals.
Ability to drive problem solving with good negotiation skills
Should be able to travel up to 10% of the working time on a request basis
3 years experience medical device regulatory affairs.
Advanced degree in scientific, technology or legal disciplines
Regulatory Affairs Certification (RAPS)
Statistics education and or training
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 device software, clinical decision systems, SaMD, etc. from an engineering, quality, or regulatory perspective is preferred.
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 requires U.S. employees to be fully vaccinated against COVID-19 unless you receive an approved medical or religious accommodation. Proof of vaccination will be required.
Relocation Assistance Provided: No