GE HealthCare is seeking a Senior Associate Regulatory Affairs Specialist to provide regulatory strategy and direction for healthcare product launches and compliance. The role requires collaboration with global regulatory bodies and focuses on executing standard activities while developing functional knowledge
Job 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.
Focuses on execution of standard enabling activities and provision of advice subject to policy and work routines within an enabling discipline with some latitude to rearrange tasks based on changing situations.
Develops strong customer relationships and serves as the interface between customer and GE, explaining technical information to others.
Matching Summary
Match Score: 75
GE HealthCare is seeking a Senior Associate Regulatory Affairs Specialist to provide regulatory strategy and direction for healthcare product launches and compliance. The role requires collaboration with global regulatory bodies and focuses on executing standard activities while developing functional knowledge.
Skills & Requirements
Must-have
regulatory strategy for healthcare products
premarket submissions and registrations
postmarket compliance management
collaboration with global regulatory bodies
execution of standard enabling activities
customer relationship development
technical information communication
Nice-to-have
strong oral and written communication skills
ability to document, plan, market, and execute programs
good interpersonal skills
basic understanding of key business drivers
problem resolution within established procedures
Key Requirements
Bachelor's degree or equivalent experience
Basic experience in Quality & Regulatory Affairs
At least 6 years of experience for USA roles
Compliance with US immigration and legal requirements