仕事概要
| 職種 | 技術職（販売、設計、開発、生産管理）／開発、研究、実験、プロジェクトマネージャー |
|---|---|
| 業種 | 医療／ その他医療 |
| 雇用形態 | 未分類 |
| ポジションレベル | その他 |
| 募集人数 | 1名 |
| 希望入社時期 | - |
| 必須語学力 |
英語 （ビジネスレベル） 日本語 （流暢に話せるレベル） |
| 活かせる語学 | - |
| 勤務時間 | その他 |
| 福利厚生・休暇 | |
| ビザ取得支援 | - |
| 外国人従業員 | - |
仕事詳細
Company Overview
Global Medical Device Maker
Job Description
1) To manage the role of Regulatory Affairs function.
2) To manage projects relevant to Regulatory Affairs (Registration, Regulatory strategy, etc.)
on time in budget.
3) To lead IVD and Medical Device registration and discuss with Japanese regulatory
agencies.
4) To lead clinical trials for IVD registration and discuss with clinical site or commercial
laboratory.
5) To lead new reimbursement request for IVD Class III (New) registered product and discuss
with Japanese MHLW to get the reimbursement.
6) To discuss and collaborate with counterpart in overseas headquarter/production and
development site.
7) To strengthen the RA organization and develop members’ talents.
Requirements
• More than bachelor's degree in Pharmaceutical Sciences or equivalent
• Experiences of management of function
• Experiences and knowledge of IVD and MD industries
• Experiences of IVD and MD registration
• Experiences of IVD or MD clinical trial for registration
• Deep knowledge of PMDA Act (including related ministerial ordinances
• Experience of discussion/negotiation with regulatory agencies
•Business level English (Frequent communication in English by e-mail, teleconference, etc.)
• Communication skills to discuss with medical doctor, professor and PMDA or MHLW officer.
• Leadership ability
面接について
連絡先
RA Manager
RGFタレントソリューションズ株式会社
800 〜 1400 万円
