Regulatory Affairs Specialist

場所: 東京都, 日本
給与: ¥7000000 - ¥10000000 per annum + competitive
セクター: 薬事申請
ジョブタイプ: 正社員

Amazing RA or Senior RA Specialist job opportunity ideal for an ambitious RA Specialist who is looking for an opportunity to broaden his/her skills at Medical Device Company with state-of-art Class IV medical devices.


As RA (Sr.) Specialist your responsibility will be to obtain and maintain the Class IV product marketing license in Japan under the specific directions from RA manager in Shanghai HQ. In order to maintain the licenses, partial change management and other relevant jobs are also required.


  • Obtain/maintain product marketing license for Class IV "Me-too" products in Japan.
  • Obtain/maintain product marketing license of MPNT products in international countries.
  • Manage product change information and manage the project of partial change, minor change and others.

<Rewards & Benefits>

  • Competitive salary package and bonus system
  • Being able to work with very innovative and famous products and the best people in the industry
  • Flex time and work-live balance
  • Great Benefit system


  • Well understanding about Japan PMDL.
  • Well communicate with Authorities in Japan (PMDA, MHLW) and CRO in regard to carrying out required tasks.
  • Experience of taking responsibilities on project planning and obtaining approval of class IV medical devices.

<Apply now>

Are you ready for a new adventure as a RA Specialist with state-of-art Class IV Medical Devices?

Please kindly apply or call Monika Ambroziak (03 4520 4041)

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。

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