Location: Tokyo, Japan Salary: ¥7000000 - ¥9500000 per annum + competitive
Sector: Regulatory Affairs (RA) Type: Permanent

Excellent job opportunity for a RA Specialist who is looking for an opportunity to broaden his/her skills at a biggest and most famous Medical Device Company: Johnson & Johnson.

DePuy Synthes Mitek Sports Medicine is the leading developer and manufacturer of orthopaedic sports medicine products, soft tissue repair devices, joint movement solutions and minimally invasive and arthroscopic solutions.

If you want to work with state-of-art device and amazing team, this is a role for you!


As RA Specialist or RA Senior Specialist you will be responsible for the whole RA process for one or more devices.

  • 薬機法に基づく規制遵守に関する全ての業務、行政対応
  • 医療機器の承認・認証申請、届出業務
  • 変更管理業務
  • プロモーションマテリアルの審査業務


  • Competitive salary package and bonus system
  • Working at most famous Medical Device Company
  • Being able to work with very innovative and famous products
  • Flex time
  • Work-live balance
  • Great Benefit system and retirement package


  • 医療機器申請担当の経験(3年以上、薬事以外でも品質保証、安全管理、QRCでの職務経験も考慮する)
  • 英語(TOEIC 600程度)
  • 材料力学、化学、電気工学又は生物学に精通していればなお可


Are you ready for a new Adventure?

薬事管理スペシャリストポジションに少しでもご興味がございましたら、Applyボタンをクリックいただき、Monika Ambroziakまでご連絡ください。

Please kindly send an email m.ambroziak(at) or call Monika Ambroziak (03 4520 4041)

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