薬事スペシャリスト（医療機器）／Vision
Core
Managing regulatory affairs for Class I medical devices in Japan, including submissions to PMDA, strategy formulation, and maintaining licenses.
Role type
Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory submissions and approvals for medical devices
Domain
Medical Devices / Regulatory Compliance
Required skills
Medical device regulatory experience (Class 1+), PMDA consultation experience, Japanese Medical Device Law knowledge, English communication, logical thinking
Preferred skills
Active implantable device experience, EMC/Electrical safety knowledge, Quality management experience, Ophthalmology knowledge
Technologies
PMDA, QMS, GVP
Responsibilities
Prepare and submit regulatory documents to PMDA, Develop RA strategies for new products, Maintain business licenses and approvals, Review promotional materials for compliance, Coordinate with quality/safety departments
Seniority
Mid-level, hands-on IC