募集要項
- 仕事内容
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<ABOUT THE POSITION><RESPONSIBILITIES>
This position is based in Tokyo and reports to Manager RA/QA JAPAC.
* Act as the Management Representative for Japan office during external audits.
* Act as the RAQA business partner for internal stakeholders
* Ensures Japan office processes comply to Japanese regulatory requirements
* Ensures that the processes and products manufactured by the company are in compliance with the Quality Assurance Agreement established between the company and the legal manufacturers.
* Keep abreast of Lean Management and Continuous Improvement tools, such as 5S, DMP, SW, and TPI to drive continuous improvement with sustainable results.
* Develop RA strategies for new product to ensure timely regulatory approvals in Japan.
* Clear communication with stakeholders about Japanese regulatory requirement.
* Establish a good relationship with government agencies, and internal stakeholders.
* Train associates on the Japanese Regulatory requirements.
* Apply CAPA and other continuous improvement tools to ensure high standards of process and product quality.
* Expertise in MHLW regulations of medical devices
* Meets the requirements to be SOKATSU
Real is part of the larger SThree K.K group
To find out more about Real, please visit www.realstaffing.com | Real についてもっと詳しく知りたい方はこちらへ→ www.realstaffing.com
Award winner of:
The Healthcare and Life Sciences Recruitment Company of the Year by TIARA Awards 2018 & 2021 | Best Large Company to Work For by TIARA Awards 2021 | Best CSR Initiative by TIARA Awards2019 | Best Workplace by Great Place to Work Institution 2018, 2020 & 2021
- 応募資格
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- 必須
- RAQA Manager
- フィットする人物像
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<QUALIFICATIONS>
* Minimum Bachelor's degree in Engineering or Life Sciences. Advanced degree for medical test, laboratory medicine, medical engineering, chemistry, biology and pharmaceutical or above is preferred.
* Extensive relevant experience in regulatory affair and quality assurance medical devices processes.
* Extensive relevant experience in Regulatory Affairs and Quality Assurance at Medical Device companies in Japan. More than 3 years' experience on similar managerial position.
* Track record in management positions with demonstrated problem solving and continuous improvement skills.
* Native level Japanese, Business level English.
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY15,000,000.00 - JPY17,000,000.00 per annum + competitive
