BRS Consultant
Takahisa Hitotsumatsu
Medical Device
Job number: JN -072024-167398
Posted: 2024-09-11
【東京】アイケア関連製品における安全管理
医療機器業務経験者必見です!
5 - 9 million yen
Tokyo
Medical Device
Quality Assurance / Quality Control
Job details
- Company overview
- The company is a Japanese optical equipment manufacturer. It engages in the development, manufacturing, and sales of precision measurement equipment. Operating in various fields such as construction, agriculture, and healthcare, it provides surveying equipment and location-based technology. Particularly in the construction industry, it offers automatic control technology for construction machinery and surveying/geospatial information systems to support efficient construction operations. In the agricultural sector, it provides equipment for automatic control of agricultural machinery and devices for precision agriculture, contributing to increased productivity and environmentally conscious farming practices. Furthermore, it develops and provides medical equipment and technology, contributing to the realization of advanced healthcare.
- Responsibilities
-
- 安全管理に関する業務全般をお任せします。
- GVP省令及び各国・地域のビジランス業務に関わる規程・手順書の策定、維持
- 安全管理情報の収集、判断の実施
- 安全確保措置の実施
- 各国法規に従った規制当局への報告
- 各国法規に従った市販後調査の実施
- 法規制に基づく販売業者の監視
- 主要販社品質保証部門に関する業務との情報連携
- Requirements
-
- 医療機器もしくは医薬品に関わる業務経験
- 英語での会議が可能なレベル（推奨：TOEIC700点以上）
- 安全管理、市販後調査の経験
- QC検定3級以上
- Salary
- 5 - 9 million yen
- Location
- Tokyo