Johnson & Johnson Careers

【Medical】 Japan, Regulatory Affairs Staff

Chiyoda, Tokyo-To
Regulatory Affairs


Job Description

Requisition ID: 1805658067W

<主な業務>
・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
 
<Job Description>

·All operations and administrative response related to regulatory compliance based on the Pharmaceutical Affairs Law.

·Application for approval and certification for medical equipment
·Change management work
·Promotional material review process


Qualifications
<職務経験>
・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)
 
<必要とする能力・スキル>
・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
 
<Experience>
· Experience of medical device application

(3 years or more. We are open to the candidates with experience of QA, safety management and QRC.)

 

<Required skills>

· English (TOEIC 600)

· Knowledge or expertise of material mechanics, chemistry, electrical engineering or biology will be highly regarded.



Primary Location
Japan-Tokyo-To-Chiyoda
Organization
Johnson & Johnson K.K. (8235)
Job Function
Regulatory Affairs
Requisition ID
1805658067W