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海外薬事
| Hiring Company | 非公開 |
| Location | Tokyo - 23 Wards |
| Job Type | Permanent Full-time |
| Salary | 4.5 million yen ~ 7.5 million yen |
Job Description
【求人No NJB2310351】
【具体的な業務内容】
医療機器の薬事申請
General Requirements
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Native |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
Required Skills
【必須条件】
・国内、欧米、もしくは中国などアジア諸国への体外診断用医薬品または医療機器の薬事申請業務経験者（3年以上）
【尚可】
・体外診断用医薬品の臨床研究経験、開発経験、学術経験、品質管理／品質保証経験者
・中国NMPA、欧州IVDD（IVDR）、米国FDA510Kの申請経験
・ISO CLSIガイドラインの理解
＜人材の特性（コンピテンシー）＞
積極的に業務に取り組み当事者意識で仕事を進められる方
部内、社外の関係者とコミュニケーションが取れる方
＜その他（スキル・知識）＞
英語で海外代理店や担当者とのコミュニケーションが取れること（TOEIC650以上）
Job Location
- Tokyo - 23 Wards
Work Conditions
| Job Type | Permanent Full-time |
| Salary | 4.5 million yen ~ 7.5 million yen |
| Work Hours | 09:00 ～ 17:30 |
| Holidays | 【有給休暇】有給休暇（入社時付与、計画年休：年10日取得推奨、最大法定＋3日）、その他 【休日】完全週休二日制 祝日 年末年始… |
| Industry | Pharmaceutical |
Job Category
- Medical, Pharmaceutical and Healthcare > Patent Specialist, Academic
