5+ years japanese medical device regulatory experience
Class ii medical device change management expertise
End-to-end renewal application leadership
GE HealthCare Technologies is seeking a Lead Specialist in Regulatory Affairs to enhance its regulatory operations in Japan, focusing on imaging medical devices. The role requires expertise in regulatory strategies and cross-functional collaboration, particularly with Class II and III devices, as well as software as a medical device (SaMD)
Job Summary
This role serves as a practical leader guiding the entire product lifecycle for imaging and digital health products in Japan.
The position involves leading regulatory strategy, managing Class II and select Class III device applications, and handling SaMD compliance.
Candidates will collaborate cross-functionally with R&D, QA, and global teams while acting as a Center of Excellence for regulatory matters.
Matching Summary
Match Score: 85
GE HealthCare Technologies is seeking a Lead Specialist in Regulatory Affairs to enhance its regulatory operations in Japan, focusing on imaging medical devices. The role requires expertise in regulatory strategies and cross-functional collaboration, particularly with Class II and III devices, as well as software as a medical device (SaMD).
Skills & Requirements
Must-have
5+ years Japanese medical device regulatory experience
Class II medical device change management expertise
End-to-end renewal application leadership
Native Japanese proficiency for official submissions
Business-level English for global collaboration
Nice-to-have
Experience with Class III medical device approvals
SaMD (Software as a Medical Device) application knowledge
GVP/GMP quality system management insights
Global team collaboration experience
STEM background or engineering degree
Key Requirements
Minimum 5 years of Japanese medical device regulatory practice
Proven independent responsibility for Class II devices
Completed end-to-end change management and renewal processes
Native level Japanese language skills
Bachelor's degree in Science or Engineering (preferred)