薬事スペシャリスト/医療機器（薬事臨床開発部）
Core
Managing regulatory affairs for Class I-III medical devices in Japan, including approval applications, strategy formulation with PMDA, and post-approval support.
Role type
Senior Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory approval dossiers and strategies for medical devices
Domain
Medical Devices / Regulatory Affairs
Required skills
Regulatory strategy, PMDA negotiation, compliance with Pharmaceutical Affairs Law, document management, risk management, logical thinking, English communication
Preferred skills
Passive device experience, Class III experience, Quality management experience, Ophthalmology knowledge, ISO 13485 internal auditor
Technologies
PMDA systems, ISO 13485
Responsibilities
Create and manage approval application documents for Class I-III devices, negotiate strategies with PMDA, respond to regulatory authority inquiries, maintain licenses and approvals, support post-approval activities like marketing material review and insurance application.