RA Director

場所: 東京都, 日本
給与: ¥15000000 - ¥25000000 per annum + competitive
セクター: 薬事申請
ジョブタイプ: 正社員
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Great RA Head opportunity for a talented RA Director / Sr. Manager interested in international position based in Tokyo for an innovative Start-up Medical Device/IVD/Oncology Company.

<Overview>

RA Director will develop and implement regulatory strategies that insure the approval of well-designed, high-quality medical devices/in vitro diagnostic tests.

<Responsibilities>

  • Provides strategic input and technical guidance on regulatory requirements to the Regulatory Affairs team members and R&D project teams.
  • Anticipates regulatory obstacles and emerging issues throughout the medical device product development lifecycle and develops solutions with other members of regulatory and related teams.
  • Interprets PMDA/MHLW medical device regulations, other global regulations and provides guidance to project teams
  • Leads regulatory policy decisions, guides and oversees preparation of documentation for regulatory government submissions for approvals and device licenses.

<Rewards & Benefits>

  • Competitive salary package and bonus system
  • Being able to work with very innovative products and the best people in the industry

<Skills>

· Advanced degree (e.g. M.Sc., Ph.D., M.D., Pharm.D.) in the Biological, Medical, Law, Chemical or Engineering field.

· Regulatory Affairs Certification preferred

· Minimum of 10 years of medical device / pharmaceutical / biologics development experience in regulatory environments, including leadership and/or senior consulting experience.

<Apply now>

Are you ready for a new adventure as a RA Director at an exciting Start-up Medical Device/IVD Company? Please kindly apply or call Monika Ambroziak (03 4520 4041)

APAC薬事部長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。

To find out more about Real Staffing, please visit www.apac.realstaffing.com

Real Staffingについてもっと詳しく知りたい方はこちらへ→ www.apac.realstaffing.com/ja

この求人に応募する