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

Janj Ja

Chiyoda, Tokyo, Japan
Medical device regulatory affairs
Regulatory submission execution
Interaction with pmda and authorities
This role supports business objectives by planning and executing necessary regulatory actions aligned with company strategy

Job Summary

  • This role supports business objectives by planning and executing necessary regulatory actions aligned with company strategy.
  • The position involves building regulatory strategies for new product introductions and negotiating with regulatory bodies to achieve timely approvals.
  • Following the planned separation, the employee will transition to DePuy Synthes and be governed by their employment policies and benefits.

Matching Summary

This role supports business objectives by planning and executing necessary regulatory actions aligned with company strategy.

Skills & Requirements

Must-have

  • Medical device regulatory affairs
  • Regulatory submission execution
  • Interaction with PMDA and authorities
  • English communication with overseas stakeholders
  • Change management for product supply
  • Compliance with pharmaceutical laws

Nice-to-have

  • Leadership in PMDA consultation
  • Team support and mentoring
  • Cross-functional project collaboration
  • Business growth and reputation maintenance

Key Requirements

  • At least 5 years medical device regulatory experience
  • Ability to read and understand English technical documents
  • Proficiency in oral and written English communication
  • Master’s degree or higher in relevant scientific fields

Work Rights

Not specified

Tailored Resume

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