APAC QARA Director

場所: Tokyo 23 wards, Japan
給与: ¥15000000 - ¥20000000 per annum + competitive
業種: 薬事申請
職種: 正社員
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Great APAC RAQA Head opportunity for a talented RAQA Director / Sr. Manager or RA Director / Sr. Manager interested in international position based in Tokyo.

<Overview>

The RAQA Director, Japan is responsible for leading all of the Regulatory Affairs, Medical Device Compliance and Quality Management Systems requirements for the CV Japan business. This individual will be a member of the CVJ Leadership team.

He/she will have a special focus upon agreeing the prioritization, communication and education on all RAQA related matters with leadership CV Japan, APAC region and global team given the significant size of the Japan business.

<Responsibilities>

  • Leads the RAQA team by partnering with the Japan (or AP or Global if need be) team
  • Keeps the VP, Regulatory Affairs and Compliance Asia Pacific and the Americas and the Regional SLT informed of the progress of ongoing registrations and statement of compliance to the Medical Devices laws of the various countries in the region.
  • Contribution as Key Management Member of local Leadership Team
  • Regulatory Affairs Process Management & Strategic Guidance to Internal Customers
  • Collaborative Work with Multiple Stakeholders
  • Quality Management Process Management
  • Etc.

<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
  • Great company culture with nicest people in the industry!

<Skills>

* In-depth knowledge of the Japan, Medical Devices Regulations. Experience working with the regional Ministries of Health. Ideally also possess APAC experience and a working knowledge of international Medical Devices regulations, especially in the Japan, Korea, China and ASEAN regulations.

* Experience in Quality Management Systems, ISO13485 and MDSAP.

* A proven track record in the management of regulatory compliance processes, Recall, Adverse Event Reporting and Clinical Studies Management.

<Apply now>

Are you ready for a new adventure as a APAC RAQA Director at one of the well-known Medical Device companies?

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

APAC薬事品質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

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