General Electric Regulatory Affairs Senior Manager in Marlborough, 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. Interprets internal and external business challenges and recommends best practices to improve products, processes or services. Utilizes understanding of industry trends to inform decision making process.
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
Developing expertise within function. Growing reputation within the organization. Includes roles that are experts in their discipline, providing professional or thought leadership. Influences policy and ensures delivery within own function, linking with other functions of the organization.
May lead functional teams or projects with moderate resource requirements, risk, and/or complexity. Presents business solutions to leaders in functional area. Communicates complex messages and negotiates mainly internally with others to adopt a different point of view. Influences peers to take action and may negotiate with external partners, vendors, or customers.
Has major influence on small business unit, a segment within a larger business unit, a family within a Function or a P&L business segment and has ownership/influence over budgets. The role is guided by functional policy. The role influences policy/operating guidelines about important subjects.
Leads others to find creative solutions to address complex problems that may impact the organization. Has the ability to evaluate quality of information received and questions conflicting data for analysis. Uses multiple internal and external resources outside of own function to help arrive at a decision.
Bachelor's Degree or a minimum of 10 years work experience
6 years experience in Pharmaceutical Clinical RA supporting development programs
Master's degree from an accredited university
Expertise in Pharmaceutical Clinical RA supporting development programs for 10+ years.
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.Note: To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years' experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.
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).
Relocation Assistance Provided: No