薬事スペシャリスト（医療機器）／Vision
Core
Managing regulatory submissions and compliance for Class I medical devices in Japan, including strategy formulation and maintaining licenses.
Role type
Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory submissions and approvals for medical devices
Domain
Medical Devices / Regulatory Affairs
Required skills
Regulatory strategy, PMDA negotiation, compliance management, document preparation, global perspective
Preferred skills
Active device approval experience, EMC knowledge, electrical safety, radio law, PSE knowledge, quality management experience, ophthalmology knowledge
Technologies
PMDA, QMS, GVP
Responsibilities
Formulate RA strategy for new product introductions, prepare and submit regulatory documents to authorities, maintain business licenses and approvals, review promotional materials for compliance, coordinate with quality and safety departments
Seniority
Mid-level, hands-on IC