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Job ID : 1539918 Date Updated : May 17th, 2025
人工内耳でシェアトップクラス オーストリア外資企業

【薬事部スペシャリスト】 医療機器の薬事申請業務

Hiring Company メドエルジャパン株式会社
Location Tokyo - 23 Wards, Chiyoda-ku
Job Type Permanent Full-time
Salary 4.5 million yen ~ 6 million yen

Work Style

Flex Time

Job Description

業務内容

  1. 医療機器の品質管理業務全般のサポート
  2. 薬事承認/認証申請、届出(主にクラスⅢの申請業務 )
  3. PMDA相談
  4. 各種業業態維持
  5. 薬事規制情報、規格情報の収集と管理
  6. 上記に関する関連業務全般
  7. 部下のマネジメント経験

General Requirements

Minimum Experience Level Over 3 years
Career Level Mid Career
Minimum English Level Daily Conversation
Minimum Japanese Level Native
Minimum Education Level Bachelor's Degree
Visa Status Permission to work in Japan required

Required Skills

【応募に必要な経験・スキル】

・薬事申請業務経験1年以上

・PCスキル

・英語(本社英文資料の翻訳が中心)
 

Job Location

  • Tokyo - 23 Wards, Chiyoda-ku
  • Chuo Line Local (Mitaka-Ochanomizu), Ochanomizu Station

Work Conditions

Job Type Permanent Full-time
Salary 4.5 million yen ~ 6 million yen
Work Hours 9:00~17:00
Holidays 土日祝日
Job Division 薬事部
Industry Medical Device

Job Category

  • Medical, Pharmaceutical and Healthcare > Patent Specialist, Academic
  • Other > Other
  • Translation and Interpretation > Translator
  • Medical, Pharmaceutical and Healthcare > Other (Medical, Pharmaceutical and Healthcare)

Company Details

Company Type Small/Medium Company (300 employees or less) - International Company
Non-Japanese Ratio (Almost) All Japanese