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Johnson & Johnson is hiring a Regulatory Affairs Leader for their Orthopaedics division in Tokyo, Japan. The ideal candidate will have extensive experience in medical device regulations and will be responsible for developing regulatory strategies and ensuring compliance with regulatory bodies.
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Job Summary
Johnson & Johnson MedTech is seeking a regulatory affairs leader to support business goals by planning and executing regulatory actions aligned with company strategy in the Orthopaedics domain.
The role involves building regulatory strategies for new product introductions, negotiating with regulatory agencies such as PMDA, and ensuring stable market supply through change management and compliance activities.
Following the planned separation of the Orthopaedics business, the employee will transition to DePuy Synthes with employment governed by their policies and benefit plans.
Matching Summary
Match Score: 75
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Johnson & Johnson is hiring a Regulatory Affairs Leader for their Orthopaedics division in Tokyo, Japan. The ideal candidate will have extensive experience in medical device regulations and will be responsible for developing regulatory strategies and ensuring compliance with regulatory bodies.
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Skills & Requirements
Must-have
Medical device regulatory affairs
Orthopaedics product expertise
Regulatory submission to PMDA
English communication with overseas stakeholders
Change management for product supply
Compliance with pharmaceutical laws
Nice-to-have
PMDA face-to-face consultation experience
Team support and leadership
Project management skills
Experience with multiple medical device classes
Key Requirements
5+ years medical device regulatory experience
Experience with Class II or higher devices
English proficiency for technical communication
Master’s degree in engineering, science, or related field