Post-market reporting and adverse event assessment
Kgmp certification and maintenance
The individual would be working with a team of Regulatory Affairs professionals to ensure GEHC Korea achieves compliance to applicable regulations
Job Summary
The individual would be working with a team of Regulatory Affairs professionals to ensure GEHC Korea achieves compliance to applicable regulations.
The role involves developing regulatory strategies, managing submissions, ensuring product compliance, and maintaining KGMP certification.
GE Healthcare is an Equal Opportunity Employer that fosters a culture of humility, trust, transparency, and ownership while offering career opportunities and comprehensive rewards.
Matching Summary
The individual would be working with a team of Regulatory Affairs professionals to ensure GEHC Korea achieves compliance to applicable regulations.
Skills & Requirements
Must-have
Regulatory submissions and compliance
Post-market reporting and adverse event assessment
KGMP certification and maintenance
Cross-functional team collaboration
English communication skills
Nice-to-have
Global communication and coordination
Regulatory intelligence and environment scanning
Advertising material review
Regulatory inspections and audit support
Effective stakeholder communication
Key Requirements
Minimum 6 years regulatory affairs experience
Bachelor’s degree in material, engineering, biotechnology, pharmacy or related