医療機器に関する薬事スペシャリスト /臨床開発/薬事 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

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製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2019年 04月 23日

求人情報

臨床開発/薬事

求人管理No.011231

会社概要

医療機器に関する薬事スペシャリスト

外資医療機器メーカーにて国から新製品の認可を取得し、販売ができるようにするための業務。

募集要項

・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 plan.
・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. And ensure compliance with internal Quality system and policy.

募集条件

  • ・薬事申請経験 5年~10年
    ・英語:ビジネスレベル
    ・既存の戦略やプロセスに固執することなくProactiveに自ら考え立案し交渉できる
    ・事業部、PMDA、グローバルとの難しい交渉を単独でマネージできる

勤務開始日

  • 応相談

雇用形態

  • 正社員

勤務地

  • 東京

転勤有無

  • なし

給与

  • ご経験に応じての額となります。