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Activated 2025-06-10
Regulatory Affairs Specialist
| Company Name |
メドエルジャパン株式会社 |
|---|---|
| Job Type |
Medical/Pharmaceutical/Bio/Fabric/Food - Patent
|
| Industry | Medical devices |
| Location |
Asia
Japan
Tokyo
Chiyoda
|
| Job Description |
[Job Description] ① Application for approval (Class III), application for certification, ② Notification (manufacturing and sales notification, minor change notification) ・Receive information from the Austrian headquarters, review the contents based on the latest notification, propose application strategies, consult with PMDA/certification bodies as necessary, and respond to inquiries. ・Apply for QMS conformity inspections as necessary to maintain surveillance surveys and standard conformity certificates, and respond to annual surveillance (obtain necessary materials from headquarters). ③ PMDA consultation (general consultation, simple consultation, various main consultations) ・Evaluate new product information and change assessments from headquarters, and consult with PMDA as necessary. ④ Application for insurance coverage ・Apply for insurance while negotiating with the Ministry of Health, Labor and Welfare. |
| Company Info |
■ Company culture We operate with a small but elite team, so we communicate closely with each department and value teamwork. ■ Smoking environment Smoking is prohibited on the premises. |
| Job Requirements |
[Requirements] - Computer operation - College graduate or above |
| English Level | Business Conversation Level (TOEIC 735-860) |
| Japanese Level | Native Level |
| Salary |
JPY - Japanese Yen JPY 6000K - JPY 8000K
（Monthly Salary Range: JPY - Japanese Yen JPY 500K - JPY 666.667K *Divided into12month ） |
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