[medtech] 薬事本部 Bura Orthopaedics Trauma/pt 薬事スタッフ

Johnson & Johnson MedTech

Chiyoda, Tokyo, Japan
**
Medical device regulatory affairs
Regulatory submission and approval
English communication with overseas stakeholders
** Johnson & Johnson MedTech is seeking a Regulatory Affairs Staff member in Tokyo to support business goals through the planning, preparation, and execution of necessary regulatory actions for medical devices. The role requires at least five years of regulatory experience in medical devices, effective communication skills in English, and the ability to work collaboratively with stakeholders. **

Job Summary

  • Johnson & Johnson MedTech is committed to healthcare innovation to prevent, treat, and cure complex diseases with smarter and less invasive treatments.
  • The role involves building regulatory strategies for new product introductions and working closely with overseas manufacturers and regulatory agencies to achieve timely approvals.
  • Following the planned separation, the employee will become part of DePuy Synthes with employment governed by its policies and benefit plans.

Matching Summary

Match Score: 75

** Johnson & Johnson MedTech is seeking a Regulatory Affairs Staff member in Tokyo to support business goals through the planning, preparation, and execution of necessary regulatory actions for medical devices. The role requires at least five years of regulatory experience in medical devices, effective communication skills in English, and the ability to work collaboratively with stakeholders. **

Skills & Requirements

Must-have

  • Medical device regulatory affairs
  • Regulatory submission and approval
  • English communication with overseas stakeholders
  • Change management procedures
  • Compliance with pharmaceutical laws

Nice-to-have

  • PMDA consultation leadership
  • Team support and mentoring
  • Cross-functional collaboration
  • Project management
  • Regulatory compliance enhancement

Key Requirements

  • At least 5 years medical device regulatory experience
  • Ability to read and understand English design and development documents
  • Effective oral and written English communication skills
  • Master's degree or higher in relevant scientific fields

Work Rights

Not specified

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