Lead Specialist, Regulatory Affairs, Japan
Core
Lead Regulatory Affairs Specialist for medical imaging devices (Class II/III) and SaMD in Japan, managing the full product lifecycle from strategy to submission.
Role type
Senior IC regulatory affairs specialist (medical devices)
Builds
Regulatory submissions and compliance for medical imaging products and software as a medical device (SaMD)
Domain
Medical technology / Regulatory Affairs / Japan
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy, Change management, Update applications, New approval applications, SaMD regulatory compliance, Cross-functional collaboration, Regulatory impact assessment, QMS audit support, Regulatory authority liaison
Preferred skills
Class III device experience, SaMD submission experience, QA/Safety knowledge (GVP/GMP), Global team collaboration, STEM degree
Technologies
None stated
Responsibilities
Develop and advise on regulatory strategy for the Japanese market; Execute change management, update, and new approval applications for Class II and Class III devices; Manage regulatory compliance for new categories including SaMD; Collaborate with R&D, QA, Safety, and Global RA teams; Review promotional materials and safety information from a regulatory perspective; Support internal and external QMS audits; Liaise with regulatory authorities such as PMDA
Seniority
Senior, hands-on IC
