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医療機器 安全管理業務

医療機器 安全管理業務

IntuitiveTokyo, JP
27日前
職務内容の詳細

Intuitiveでは、果たすべき使命に向けて皆で団結して取り組みます。当社は、低侵襲治療は生活をより豊かにする治療であると考えています。独創性とインテリジェントなテクノロジーを通じて医師の潜在能力を広げ、制約なく治療できるようにします。

25年以上にわたり、世界中の病院や医療チームと協力して、ヘルスケアのいくつかの最も困難な課題の解決を支援し、可能なことを前に進めてきました。

Intuitiveは、さまざまなバックグラウンドを持つ優秀な人材の努力によって成り立っています。優れたアイデアはどこからでも得られると信じ、私たちは、思考の多様性と相互の尊重に根差したインクルーシブな文化の醸成に努めます。また、包摂性（インクルージョン）を持ってチームメンバーを指導し、ありのままの自分で最高の仕事ができるよう力づけます。

Primary Function of Position :

The Senior Safety Control Specialist is responsible to insure timely post-marketing filings (GVP) and complaint handling filings. Maintain post marketing and complaint handling documentation with necessary filings and communications to appropriate parties. Communicate with government / regulatory agencies on a local basis. Support the quality management activity in cooperation with QA team. Prepare and maintain SOP for post-marketing filing, complaint handling and quality management.

Roles and Responsibilities :

  • Preparation and implementation of GVP in compliance with Japanese PAL.
  • Collection and first reviewer of local and overseas post-marketing safety information.
  • Review / approve the evaluation of local and overseas post-marketing safety information.
  • Manage an outsourced contractor daily work.
  • Complaint handling management for filings and prepare the customer letter.
  • Communication with head office on complaint cases for preparation of customer letter.
  • Support quality management activity and work with QA team to maintain the appropriate quality management system.
  • Prepare and maintain the appropriate SOP for post-marketing filing, complaint handling and quality management in a timely manner.
  • Continuous improvement and management of the safety / quality assurance process in accordance with Intuitive Surgical Product Development Process.
  • Work directly with regulatory agencies on safety / quality issues and submissions.
  • Documentation of Package Insert and PMDA web maintenance of Package Insert

Skill / Job Requirements :

  • Educated and trained for post-marketing and / or quality management duties.
  • Excellent ability to work in cross-functional environments.
  • Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory documents.
  • 3-5 years’ Experience working directly with the MHLW and other governmental agencies on Post marketing matters and / or Quality assurance matters.
  • Friendly, positive attitude which fosters cooperation.
  • Careful documentation of every step in a field action.
  • Careful follow up of information sent to users and regulatory agencies.
  • Understanding of Japan and international regulations regarding medical device safety / quality management.
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    医療機器　安全管理業務 • Tokyo, JP