The Lead Regulatory Affairs Specialist position at GE HealthCare UK is focused on providing regulatory strategy and direction for product launch and compliance in the healthcare industry. The ideal candidate will have extensive experience in regulatory affairs, particularly in Japan, along with strong communication skills in both Japanese and English
Job Summary
The role provides strategic regulatory direction for healthcare industry requirements regarding product launches and post-market compliance in Japan.
Candidates must possess advanced Japanese language skills to understand regulatory documents and generate high-quality submission packages.
The position requires a professional who can operate with autonomy while fostering a supportive and collaborative team environment.
Matching Summary
Match Score: 85
The Lead Regulatory Affairs Specialist position at GE HealthCare UK is focused on providing regulatory strategy and direction for product launch and compliance in the healthcare industry. The ideal candidate will have extensive experience in regulatory affairs, particularly in Japan, along with strong communication skills in both Japanese and English.
Skills & Requirements
Must-have
5+ years product registration experience
Advanced Japanese language proficiency
Business level English communication
Cross-functional team collaboration
Regulatory submission preparation
Nice-to-have
QA or Safety Management experience
Servant leadership mindset
Growth mindset and innovation
Lean methodology application
Remote work communication skills
Key Requirements
Minimum 5 years of independent product registration experience
Advanced Japanese language skill required
Business level English writing, reading, and speaking