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Open nowPosted 921 days ago

Senior Regulatory Affairs Specialist

Randstad Sourceright - Japan319 open roles

Where
Tokyo
Work mode
On site
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Your applicationOpen nowSenior Regulatory Affairs SpecialistRandstad Sourceright - Japan · Tokyo

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Randstad Sourceright - Japan's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: posted 921 days ago

The posting

Main Responsibilities

  • 製造販売承認取得及び既存製品の維持管理業務
  • 製品の特性やニーズに沿った承認申請戦略の立案
  • 申請戦略及び製造元の原資料に基づく承認申請書の作成
  • 行政当局からの照会に対する回答、社内部署や製造元との連携
  • 法や通知に対する日常的な知識習得及び理解
  • 添付文書、QMS申請、保険適用希望書の作成
  • 販売促進資料の法的要求に関わる確認
  • 製品の変更管理に関する判断

Must Haves

  • 製品知識を習得する学習能力、文章表現能力（日本語及び英語）
  • 英語力（メール、技術文書読解、コミュニケーションレベルでのビジネス実務利用経験）
  • 円滑なコミュニケーション能力、調整力、渉外力、説明能力
  • 論理的思考力、問題解決意識、当事者意識、自立心、向上心
  • ５年以上の医療機器薬事申請経験又は医療機器開発経験
  • 次のうち1つ以上の経験：①AI又は医療機器ソフトウェアの薬事申請又は開発、②臨床試験付きの製品の薬事申請、③医用電気機器の薬事申請

Nice to Haves

  • 科学的基礎知識（電気、化学、材料工学、ライフサイエンス）
  • 医療機器の設計、品質管理、製造の基礎知識
  • 海外カウンターパートとの業務遂行経験、海外出張経験
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  1. A CV for this posting

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  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Randstad Sourceright - Japan's form

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    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

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    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

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