RA Manager
Cutera
Tokyo, Tokyo, JP
2 日前

会社概要

キュテラ株式会社について

医療機器レーザー 光治療器の販売 修理 アフターサービス 化粧品の製造販売及び輸 を提供する 国キュテラ社の 本法 本法 では美容 医療機器 化粧品のマーケティ ング 販売 修理などを っています

求人内容

  • Collaborate with senior management in the development of regulatory strategies to gain approvals for Cutera medical devices and cosmetics in Japan
  • Author, manage, and coordinate regulatory submissions for Cutera medical devices and cosmetics in Japan
  • Interact with respective regulatory agencies
  • Provide expertise in translating regulatory requirements into practical, workable plans
  • Provide regulatory intelligence on changes in medical device and cosmetics regulations in Japan
  • Serve as Marketing Supervisor General for Cutera medical devices and cosmetics
  • Supervise or concurrently serve as the Quality Controller (GQP) and / or Safety Controller (GVP)
  • Decide on necessary measures, such as recalls, and give instructions to the Quality Controller, Safety Controller, and other relevant departments
  • Decide on necessary measures based upon reports from the Quality Controller and Safety Controller and give instructions for the implementation of such measures to the Quality Assurance department, Safety management department and other departments involved in Quality control and Safety management duties
  • other duties as assigned
  • Project budget management and progress management
  • People Management within Cutera KK RA team
  • 資格

    Bachelor of Science in life sciences or equivalent, with a minimum of 7+ years related regulatory experience in the medical device industry.

    Experience, knowledge and success in the preparation and supervision of major regulatory submissions and supporting documents.

    Excellent regulatory, technical, and problem solving skills.

    Understanding of relevant regulations and quality assurance requirements, and demonstrated ability to manage regulatory and quality assurance activities and deliver against program timelines.

    English communication skills without hesitation of engaging in scientific / technical discussions in English

    Experience,knowledge in application approval of Quasi-drug

    その他の情報

    All your information will be kept confidential according to EEO guidelines.

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