RA Med Device @ Global Regulatory Consulting Full Remote

東京23区 外資系企業 年収 800万円 - 1500万円 外資系企業 View Job Description
Take lead in medical device RA activities for client needs on various projects. Act as a key consultant for class I-IV products for local regulations.
  • Take lead in medical device RA activities for client needs on various projects
  • Act as a key consultant for class I-IV products for local regulations

企業情報

  • Global Regulatory/Quality consulting company specialising in the pharmaceutical, medical device, cosmetic areas
  • Rich project pipeline working with some of the top health care companies in the industry to support in regulatory and quality activities
  • Japan business grew exponentially within the past 5 years due to demand
  • Fully remote
  • International environment with extensive global collaboration

職務内容

  • Support the planning and implementation for product registration in class I-IV products for the company's medical device clients
  • Cover in various areas including in SaMD for end-to-end process of the product registration
  • Be the SME for the business when it comes to RA area
  • Ensure product registration translation work is correctly done
  • Provide any local/regional regulatory intelligence
  • Communicate with local health authorities (PMDA, MHLW, Prefecture bodies)

理想の人材

  • University degree in scientific or related area
  • High fluency in English and Japanese (non-native level speakers will not be selected)
  • RA experience in the medical device industry
  • Track record of submitting products for class I-II (class III-IV preferred) to the PMDA
  • Experience in SaMD is preferred
  • Ability to communicate, negotiate, develop relationships with local health authorities

条件・待遇

  • Competitive salaries and benefits
  • Great work life balance
  • Fully remote option
  • Amazing career progression in RA Medical Device
  • Work with industry leaders who are solving various unmet medical needs
  • International working environment
コンタクト
Zach Itozu
求人番号
JN-032025-6687997
電話
+813 6832 8683

求人情報

分野
ライフサイエンス
職種
薬事・学術
業界
ヘルスケア・製薬
勤務地
東京23区
雇用形態
正社員
担当コンサルタント
Zach Itozu
担当コンサルタントの電話番号
+813 6832 8683
求人番号
JN-032025-6687997
企業タイプ
外資系企業

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