Associate Manager, MedSurg Regulatory Affairs

About the role

The Associate Manager will support regulatory affairs for medical‑surgical devices, ensuring smooth approval and compliance processes. Working under minimal supervision, the role requires strong knowledge of Japanese medical device regulations and effective project coordination.

Key responsibilities

• Prepare and submit manufacturing and distribution certification approvals and notifications, including planning, project management, data collection, and responding to PMDA/NB queries.
• Maintain existing approvals and certifications through change control and periodic renewal activities.
• Conduct QMS compliance inspection applications.
• Prepare insurance listing applications and related documentation.

Required profile

• At least 3 years of experience in medical device regulatory approvals.
• Strong communication and project management skills.
• Ability to write business documents in English.
• Experience with PMDA/MHLW consultation meetings is preferred.
• Knowledge of medical electrical equipment is a plus.

Required skills

• Regulatory affairs for medical devices (Japanese market).
• Project management of approval submissions.
• English business writing.
• Interaction with PMDA and MHLW authorities.
• QMS compliance processes.
• Insurance listing preparation.