RAQA Specialist and Manager

東京都 正社員 日系企業 View Job Description
Develop an effective regulatory strategy for each project from a broad perspective and achieve active product introduction.Proactively advance each project with skills to deliver powerful, compelling messages while maintaining good communication with various parties at BD / Medicon, MHLW / PMDA, and industries.Understand PMDA / MHLW's thinking and successfully negotiate for the benefit of BD / Medicon and projects.
  • hybrid working arrangement.
  • Competitive salary and benefits.

企業情報

A leading global medical technology company that creates medical technology, devices, and laboratory equipment for various needs across the healthcare sector.

職務内容

  • Develop an effective regulatory strategy for each project from a broad perspective and achieve active product introduction.
  • Develop logical thinking, simplify complex information, and provide logical explanations.
  • Proactively advance each project with skills to deliver powerful, compelling messages while maintaining good communication with various parties at BD / Medicon, MHLW / PMDA, and industries.
  • Understand PMDA / MHLW's thinking and successfully negotiate for the benefit of BD / Medicon and projects.
  • Enhance internal compliance and risk management system based on an understanding of the Japanese PMD Act and other business-related laws and regulations.

理想の人材

  • Has an experience in regulatory affairs for class I / II / III / IV medical devices in a medical device company, or a Contract Research Organization (CRO).
  • Business level English.
  • Strong interpersonal skills are required in the areas of verbal and written communications, focus on regulatory bodies, appropriately responsive to service to internal business needs, coaching, influencing, and team building with a growth mindset

条件・待遇

We embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve the strategic imperatives of the organization. Our leaders are committed, engaged, and accountable to making talent our top priority

コンタクト
Aiko Estrellado
求人番号
JN-112023-6264082
電話
+81 3 5733 7166

求人情報

分野
医療・ヘルスケア
職種
ヘルスケア
業界
ヘルスケア・製薬
勤務地
東京都
雇用形態
正社員
担当コンサルタント
Aiko Estrellado
担当コンサルタントの電話番号
+81 3 5733 7166
求人番号
JN-112023-6264082
企業タイプ
日系企業

ダイバーシティ&インクルージョン

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