BRS Consultant
Shotaro Tsubaki
Medical Device
Job number: JN -072024-4978
Posted: 2024-09-11
RA Manager
People Management経験不問です！
7 - 10 million yen
Tokyo
Medical Device
Regulatory Affairs (RA)
Job details
- Company overview
- We are an innovative solution provider specializing in the health and wellness sector in Japan. The company develops medical devices and healthcare solutions based on advanced technology and in-depth understanding. This helps improve the quality of healthcare and optimize patient care, thereby contributing to better health. The company also pursues sustainable innovation and contributes to improving health and wellbeing in society. We are committed to providing comprehensive healthcare solutions through a variety of partnerships and collaborations.
- Responsibilities
-
- 製造販売承認／認証申請、届出（計画立案、資料取集、PMDA／NB 照会対応）
- 承認／認証の維持管理業務（変更管理、定期更新）
- QMS適合性調査申請
- 保険収載業務（保険適用希望書作成等）
- Requirements
-
- 薬事申請の実務経験を7年程度以上有する方
- 医薬品医療機器等法（承認申請、QMS、保険）に関する基本的な知識
- Clinicalの経験、知識をお持ちの方
- 日本語：母国語レベル（もしくは、読み書き含め、極めて流暢な方）
- 英語：ビジネスでの使用経験のある方 ※場合によっては、英語での面接も実施します。
- Salary
- 7 - 10 million yen
- Location
- Tokyo