Senior Regulatory Affairs Specialist, Japan

1週間前

Nakano City Cook Medical Full time

Overview

Senior Regulatory Affairs Specialist, Japan (work hybrid)

シニアスペシャリストとして、以下の日本での薬事業務を担って頂ける人材を募集致します (As a Senior Regulatory Affairs Specialist, we are looking for a person who is willing to take responsibilities for the following regulatory work in Japan):

  • 医療機器の承認、認証、届出に関する業務の遂行 (Implement on Regulatory Approval, Certification, Notification activities for Medical Devices)
  • 製造元を含む社内外の顧客に関する交渉 (Negotiation with In-house and/or Outside customers including each Cook Manufacture)
  • 製造元および社内のおける薬事コンサルタント (RA Consultation for each division at Cook Japan and Cook Manufactures)
  • 人材育成補助 (Assist for Talent Development)
  • プロジェクトおよび時間管理 (Projects and Time management)

    • Responsibilities

  • 薬事申請におけるCook Japanと各製造所間の調整 (Coordinate for timely Regulatory Submissions between Cook Japan and Cook Manufacturers)
  • 申請書類(日英)の作成とレビュー、ならびにタイムリーな承認取得のためのPMDAや他の薬事機関からの指摘照会への対応 (Preparation and review of Regulatory Submission dossiers (in Japanese or English), and correspondance to inquiries of PMDA or other regulatory agencies in order to obtain timely approval)
  • Cook JapanおよびCook製造所における薬事的なスキルを改善するためのトレーニング資料の作成 (Create training documents to improve regulatory skills in Cook Japan and at Cook
  • Cook JapanおよびCook製造所のスタッフの薬事的なスキルを改善するためのトレーニングサポート (Support employees' training to improve regulatory skills in Cook Japan and at Cook
  • Cookの目的のためのPMDAとの交渉 (Negotiate with PMDA on behalf of Cook objectives)
  • 必要に応じて保険償還取得のサポート (Support reimbursement efforts if needed)
  • 個々の薬事申請に対するCookグループのVisionを理解し、Cook Japanにおける申請プロジェクトにおいてリーダーシップを発揮できる (Learn the Cook Group vision for each regulatory submission and be able to provide leadership for submission projects in Cook Japan)
  • COOK行動規範および企業法令順守要求事項を健全に理解と遵守 (Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements)
  • 事業部の営業活動を最大化、薬事要求事項およびプロモーションコードを含む業界における要求事項への適合させるための協力者となる (Work as a collaborator for SBUs to maximize their activities and to comply with regulatory requirements and Industrial requirement including Promotional Code)
  • GTW/RIMS/Intranet上での薬事書類および法令等の電子的データベース(電子書庫)の体系化(Organize electronic database (electronic library) of Regulatory Documents and government notifications on GTW (Global Technical Warehous)/RIMS (Regulatory Information Management System)/Intranet)

    • Qualifications

  • 英語会話能力TOEIC700以上もしくは同等資格 (English communication capability, TOEIC 700+ or equivalent)
  • 外資系企業での勤務経験 (Experience working for International companies)
  • 医療機器業界での5年以上の薬事経験 (Over 5 years' experience in regulatory for medical device industry)
  • PMDAとの交渉経験 (Experience negotiating with PMDA)
  • 対人スキル (Interpersonal skills)
  • 問題解決スキル (Problem-solving skills)
  • マイクロソフトオフィスソフトへの熟練 (Familiarity with Windows Office Software (. Word, Excel, Power Point, Outlook, Project, OneNote, SharePoint)

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