Johnson & Johnson is seeking a Regulatory Affairs Staff member for its Bura Orthopaedics Trauma/pt division in Tokyo. The role involves developing regulatory strategies, managing submissions, and ensuring compliance with regulations to support business objectives
Job Summary
Plan, prepare, and execute regulatory actions to support business objectives in alignment with company strategy.
Develop regulatory strategies for new product introductions, liaise with overseas manufacturers, and negotiate with regulatory bodies like PMDA for timely approvals.
Ensure stable market supply and manage product discontinuation processes in compliance with regulations and internal policies.
Matching Summary
Match Score: 85
Johnson & Johnson is seeking a Regulatory Affairs Staff member for its Bura Orthopaedics Trauma/pt division in Tokyo. The role involves developing regulatory strategies, managing submissions, and ensuring compliance with regulations to support business objectives.
Skills & Requirements
Must-have
Medical device regulatory affairs experience
English comprehension and communication
Regulatory strategy development
Post-market change management
Compliance with laws and regulations
Nice-to-have
Proactive project leadership
Team support and mentorship
Advertising review
Organizational project contribution
Key Requirements
Minimum 5 years of medical device (Class II or higher) regulatory affairs experience
English proficiency for reading design documents and communicating with overseas stakeholders
Master's degree or higher in relevant scientific fields (preferred)