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Medtronic Tokyo, 日本Job Title: Clinical Study ManageR · Department: クリニカル・メディカルアフェアーズ臨床開発戦略推進 · Reporting to:臨床開発戦略推進 DIVISIONマネージャー · 背景 · 臨床開発本部は、日本国内外の臨床試験(治験)を通じて新しい医療機器の有効性と安全性を評価・検証し、厚生労働省(医薬品医療機器総合機構)へ承認申請を行い医療機器として製造販売承認を取得する業務を担います。そして製造販売承認を取得した新医療機器等に対しては、日常の診療において機器を使用したときの医療機器の品質、有効性及び ...
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(株)UL Japan Tokyo, 日本■クライアントのニーズと要件を確認し、ベストプラクティスや共通のアプローチについてアドバイスを提供するコンサルティングをお任せいたします。 · ◇製品提供の1つまたは複数の領域で製品の導入の専門知識を提供 · ◇クライアントのニーズと要件を評価し、ベストプラクティスや共通のアプローチについてアドバイスを提供 · ◇クライアントの要件に基づいてソリューションオプションを特定し、仕様書を作成 ...
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Red Hat K.K. Tokyo, 日本 フルタイムJob Summary: · Red Hat Japan is seeking a Senior Communications Specialist who will be based in our Tokyo office. This is a multi-disciplined role that covers public relations, analyst relations and internal communications programs for Red Hat Japan. As the country communication ...
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Rakuten Tokyo, 日本 フルタイムDescription · : Department Overview · This role belongs to the IT Security Group within the Information Security & Privacy Governance Department. Our objective is to develop measures to ensure that our organizational data remains secure. While doing this, we often partner with ...
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DOW CHEMICAL JAPAN LIMITED Tokyo, 日本 フルタイムDescription · Dow has an exciting opportunity for a Senior Sales Specialist in Dow Industrial Solutions (DIS) business, located in Tokyo, Japan. · You will work with the team and contribute to the business growth and differentiation of DIS business. · Job is an account managemen ...
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Ansys Tokyo, 日本14189 · Summary / Role Purpose · The Japan Senior Field Marketing Specialist will develop, manage marketing plans and programs by works closely with key program stakeholders including APAC /Japan Automotive and Strategic Sales and regional technical/support engineering teams. ...
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Amazon Web Services Japan GK Tokyo, 日本 フルタイムAre you a customer-obsessed builder with a passion for helping customers achieve their full potential? Do you have the business savvy, Enterprise Applications, Migration and Modernization (EAMM) background, and sales skills necessary to help position AWS as the cloud provider of ...
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DOW CHEMICAL JAPAN LIMITED Tokyo, 日本 フルタイムDescription · : Key Responsibilities · • Account management on new/existing customers and distributors to generate sales and reach to the target plan · • Account plan execution with leadership among production team, supply chain/logistics/CSR, and marketing managers to initiate ...
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Abbott Laboratories Shinjuku-ku, 日本 フルタイムMAIN PURPOSE OF ROLE · Supervises the day to day activities of staff that comprise the accounting function to ensure including accounts payable, accounts receivable, joint interest billings, revenue and asset accounting. · Responsibilities may include other accounting functions s ...
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Philips Tokyo, 日本 フルタイムJOB DESCRIPTION Job Title · Regulatory Affairs Senior Specialist Job Description · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven b ...
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Stryker Tokyo, 日本 フルタイムAre you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do Here, we provide our RA/QA team the opportunity to learn new things, as well as endless ...
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Stryker Tokyo, 日本 フルタイムAre you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do Here, we provide our RA/QA team the opportunity to learn new things, as well as endless ...
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ServiceNow Tokyo, 日本 フルタイムJob DescriptionIn this Japan-based role you will serve as a trusted advisor to ServiceNow partners operating in the Japan market. · Drive cross-functional collaboration to execute Practice growth strategies to meet the capacity and competency needs of the Japan market and Service ...
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Coty Tokyo, 日本Mission · Ensure that Coty Japan operates within Japan regulatory and safety regulations · Essential Functions · Coty Japan Regulatory Affairs. Mainly carry out application work for cosmetics · Perform the duties of Safety Control Manager for Coty Japan. 安全管理責任者(安責) · Key Role & ...
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Zendesk Tokyo, 日本 フルタイムJob Description · Job Summary: · We are in search of a dedicated and experienced Workplace Specialist to optimize our office operations in Japan. The ideal candidate will be proficient in reception duties and have a strong background in workplace management, ensuring efficient ut ...
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Wiley Tokyo, 日本Senior Specialist, People Business Partner · Location: Tokyo, Japan · Address: Nomura Fudosan Nishi Shinjuku Bldg 8F, 8-4-2 Nishi-Shinjuku, Shinjuku-ku, Tokyo東京都新宿区西新宿8-4-2野村不動産西新宿ビル8階 f · Our mission is to unlock human potential. We welcome you for who you are, the backgroun ...
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Abbott Laboratories Tokyo, 日本 OTHERCORE JOB RESPONSIBILITIES · Responsible for the flow of day to day warehouse activity, including receiving, inspection, inventory management, shipping, delivery through freight forwarder networks. · Communication to work with global and domestic team on internal and external cust ...
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SAP Tokyo, 日本 Regular フルタイムWe help the world run better · Our company culture is focused on helping our employees enable innovation by building breakthroughs together. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences, values flexibility, an ...
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Organon Tokyo, 日本 フルタイムJob Description · The Position · The Pharmacovigilance Senior Specialist (PV Senior Specialist) will be a part of Regional Regulatory Affairs and affiliate Pharmacovigilance organization and reporting into the head of Japan Pharmacovigilance. · The PV Senior Specialist is respons ...
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Abbott Tokyo, 日本 フルタイムMAIN PURPOSE OF ROLE · Supervises the day to day activities of staff that comprise the accounting function to ensure including accounts payable, accounts receivable, joint interest billings, revenue and asset accounting. · Responsibilities may include other accounting functions s ...
Senior QA Specialist - Tokyo, 日本 - Thermo Fisher Scientific
説明
医療機器、体外診断用医薬品、動物用医薬品、研究用試薬(消耗品、機器含む)に係る品質保証業務
職務内容:
他の品質保証担当者と連携し、Quality Manage System (QMS)の運営、維持管理の実施していただきます 。
・QMS関連文書の新規作成及び改訂
・関係部門との協働による新製品の市場上市計画の策定と実行
・法定表示ラベルの作成、改定
・製造販売開始および変更時におけるリスク分析の実施
・内部監査および供給業者の評価の実施
・国内製造委託業者の管理
・不具合発生時の海外製造所への報告、連携による原因調査、是正・予防処置、顧客報告の実施
・QMS適合性調査対応
・製品の製造販売承認/認証申請時のQMS適合性調査申請資料の作成、QMS適合性調査対応
必要とされる資格・経験
・医療機器又は体外診断用医薬品分野における3年以上の品質保証業務経験
・規制当局又は認証登録機関によるISO13485適合性調査対応経験
・ビジネスレベルの英語力(技術資料の読解、メール及び電話会議対応)
歓迎される資格・経験
・チームリーダー又はチームマネジメント経験(People managerであるかは問わない)
・当社研究用の各種機器・分析用試薬、または同業他社製品の知見
・SAP等各種ERPシステムの使用経験
