Regulatory Affairs Specialist | 薬事スペシャリスト

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募集要項

会社概要

同社は医療機器の開発と販売を専門としています。主に心血管、泌尿器、消化器などの分野で使用される高度な医療機器を提供しており、患者の治療や診断を支援します。革新的な技術と研究開発を重視し、医療現場のニーズに応える製品を次々と市場に投入しています。製品ラインナップには、カテーテルやステント、内視鏡機器などがあり、高い品質と安全性を誇ります。また、医療専門家との協力を通じて、効果的な治療法の普及と医療技術の向上を目指しています。患者の生活の質向上をミッションに掲げ、グローバルなネットワークを活用して、世界中の医療機関に優れたソリューションを提供しています。

業務内容

Main responsibilities:

• Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation.
• Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation.
• Provide management team with regular updates on product registration and new regulations from government body. 
• Provides input on regulatory- related issues associated with compliance and achieving the business plans. Prioritize and plan on product registration for his/her respective product lines. 
• Preparing, coordinating and submitting regulatory applications to the local health authority. 
• Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.
• Provide the management team with regular updates on product registration.
• Ensure product registrations are reviewed and renewed as required. 
• Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education. 
• Lobby the local health authorities using constructive/scientific challenges to regulations.
• This should include guidance on alternative solutions to country regulatory needs. 
• Supports tender operations by timely supply of accurate regulatory documents. 
• Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies. 
• Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation. 
• Serves as regulatory consultant to marketing team and government regulatory agencies. 
• Complete the mandatory Quality training subject to the defined timeline.
• Ensure compliance with internal Quality system and policy.

応募条件

Minimum requreiments:

• Industry experience in any of the following:
  • Clinical development, R&D or QA experience in the healthcare industry
  • Any experience in the medical device industry
  • Regulatory positions in industries other than healthcare (e.g. consumer goods, cosmetics, etc.)
• English level: business (reading and writing) *Those applying for pharmaceutical affairs must be able to handle telephone calls and meetings in English

Preferred qualifications:

• 5+ years of pharmaceutical affairs application experience (less than manager)
• Can independently manage difficult negotiations with business divisions, PMDA, and global
• Those currently learning the English language are also considered for potential hires

給与

700 - 1000 万円

勤務地

東京