Manager, Orthopaedics, Regulatory Affairs

About the role

The Manager, Orthopaedics, Regulatory Affairs will lead the preparation and submission of approval applications and notifications for medical devices manufactured and distributed by Stryker Japan. Working under minimal supervision, the role ensures compliance with Japanese pharmaceutical and medical device regulations.

Key responsibilities

• Prepare and submit manufacturing and distribution approval applications, including planning, data collection, and responding to PMDA/NB queries.
• Maintain existing approvals and certifications through change control and periodic renewal processes.
• Handle QMS compliance inspection applications and insurance listing submissions.

Required profile

• Minimum 6 years of experience in medical device regulatory approvals (Class I‑IV) in Japan.
• Proven experience with PMDA consultations and approval of improved devices, preferably Class IV.
• Strong communication and project‑management skills to coordinate with QC, WA, Sales, Marketing, Operations, and Customer Care.

Required skills

• Medical device regulatory affairs expertise, especially Japanese PMDA processes.
• Ability to draft business documents in English.