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Jobs list of Medical Device

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  • Job number: JN -072024-39178 Posted: 2024-09-11

    Marketing / Content Creator (Medical Device) | マーケティング・コンテンツ制作担当(医療機器)

    マーケティング経験が活かせます
    5 - 7 million yen Tokyo Medical Device Marketing

    Company overview
    The company is a Japanese optical equipment manufacturer. It engages in the development, manufacturing, and sales of precision measurement equipment. Operating in various fields such as construction, agriculture, and healthcare, it provides surveying equipment and location-based technology. Particularly in the construction industry, it offers automatic control technology for construction machinery and surveying/geospatial information systems to support efficient construction operations. In the agricultural sector, it provides equipment for automatic control of agricultural machinery and devices for precision agriculture, contributing to increased productivity and environmentally conscious farming practices. Furthermore, it develops and provides medical equipment and technology, contributing to the realization of advanced healthcare.
    Responsibilities
    マーケティング担当として下記業務をお任せします。※海外出張あり頻度は業務内容に依る
    業務内容:
    マーケティングコンテンツデザイン業務(コンセプトからビジュアル提案を行い、またデザインの実務作業も行う)
    イベントブースデザインレイアウト企画業務
    ブランディングに関わるデザイン企画業務(一貫したトンマナやデザインエレメントのデザイン戦略の企画提案を行う)
    コンテンツ制作に関する予算・スケジュール管理、アウトソースへのデザイン発注及び進行管理などのディレクション業務
    想定される媒体:カタログ、広告、SNSグラフィック、展示会グラフィック、ロゴ企画、ビデオ、製品撮影、など
    Takahisa Hitotsumatsu
    Takahisa Hitotsumatsu
    Medical Device
  • Job number: JN -072024-23485 Posted: 2024-09-11

    リコン クリニカルスペシャリスト

    【東京】手術支援ロボットのクリニカルスペシャリスト
    5 - 8 million yen Tokyo Medical Device Clinical Specialist

    Company overview
    Our client is a driving force in health care industry, specializing in technologies and a wide portfolio of related products and services.
    Responsibilities
    職務要約:
    整形外科領域における顧客に対し、製品導入に向け説明会の実施、実機を使用したトレーニングを実施する、製品導入意思のある顧客に対し安全使用できる環境構築のためCertification Trainingを実施する
    整形外科領域の疾患及びエビデンスの収集及び理解と適正な情報提供が実施できる
    Sales Team Memberと連携し、導入施設の継続的な適正使用環境を構築するために、術前(院内環境の確認)、術中(適正手術手技、安全使用)術後(使用方法、術中データフォロー)及び継続したサービス体制の構築を実行していく
    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -072024-4098 Posted: 2024-09-11

    【幡ヶ谷】品質保証

    大手日系企業の品質担当
    5.5 - 7.5 million yen Tokyo Medical Device Quality Assurance / Quality Control

    Company overview
    We are a leading Japanese manufacturer and distributor of medical devices and related products. We have a particularly strong reputation in the field of medical devices, such as catheters and artificial heart-lung machines, and we are expanding our business widely both domestically and internationally. We are also expanding into the fields of pharmaceuticals and blood systems, providing comprehensive medical solutions. We focus on innovation and quality control, and develop our products with patient safety and healthcare professionals\' convenience in mind. We aim to contribute to the development of healthcare from a global perspective and are actively involved in the realization of a sustainable society.
    Responsibilities
    品質マネジメントシステム改善
    各国規制への適合化に関する業務
    Shotaro Tsubaki
    Shotaro Tsubaki
    Medical Device
  • Job number: JN -072024-18086 Posted: 2024-09-11

    Clinical Traning Specialist

    元看護師・臨床工学技士の方優遇案件です
    7 - 9 million yen Tokyo Medical Device Training / Education

    Company overview
    We are a Japanese medical device manufacturer aiming to improve patients\' quality of life as a global medical company. We develop, manufacture, sell, and service medical devices for the treatment and measurement of severe cardiovascular diseases, particularly excelling in artificial heart valves and valvuloplasty products for valve disease treatment, as well as critical care products like hemodynamic monitoring systems. We emphasize environmental protection, social contribution, and corporate governance responsibilities, promoting sustainable initiatives. Additionally, we provide support information and educational tools for healthcare professionals worldwide.
    Responsibilities
    Develop and execute physician training programs and events. Provides expertise and clinical insights on the device, procedure and protocol throughout the life cycle of the clinical case.
    Key Responsibilities
    Develop external training curriculum and manage all activities.
    Partner with Global Business Unit to develop material content and communications for distribution to clinical sites, including Japanese translation of technical terminology.
    Document procedural case observations for insights in investigating post procedural events.
    Develop and continuously improve training materials, training tools, and curriculum, based on clinical trial experience.
    Other incidental duties
    Shotaro Tsubaki
    Shotaro Tsubaki
    Medical Device
  • Job number: JN -072024-22560 Posted: 2024-09-11

    体外診断機器・試薬の商品企画 /海外マーケティング・事業企画

    日系大手医療機器メーカーの注力事業
    6 - 10 million yen Tokyo Medical Device Business Development

    Company overview
    We are a major corporation based in Japan, offering a wide range of products and services. Beyond just photographic film and cameras, we also specialize in medical equipment, chemicals, optical devices, and more. Our focus is on the quality, innovation, and sustainability of our products, providing value to customers worldwide. Additionally, we prioritize research and development, contributing to advancements in science and technology.
    Responsibilities
    (1、2、3のいずれか)(1)商品企画および商品化プロジェクト推進担当体外診断機器(IVD医療機器)・診断薬(免疫、生化学)の新規商品企画及びプロジェクト遂行
    (2)学術・営業技術実務担当体外診断機器(IVD医療機器)・診断薬(生化学、免疫、遺伝子)及び検査サービスの学術活動・営業技術の遂行
    (3)マーケティング/事業企画推進担当体外診断機器(IVD医療機器)・診断薬(生化学、免疫、遺伝子)のマーケティング/事業企画の遂行
    マーケティング施策、販売施策/販売計画の立案・推進・遂行管理、新規流通チャネル・顧客開拓営業、商品化への市場情報フィードバックや新製品の市場導入など
    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -072024-19149 Posted: 2024-09-11

    【東京】再生医療機器 / 薬事・安全管理

    【東京】再生医療機器の薬事
    6 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)

    Company overview
    Our client is selling, importing and exporting pharmaceuticals and other products.
    Responsibilities
    医療機器に関する法規制対応業務のうち、以下:各国 製品登録関連業務(日本 薬事承認・認証等取得および維持管理。米国 510(k)・PMA 等海外の承認・認証取得および維持管理。当局相談 等)
    各国 安全管理業務(治験等市販前~市販後を通して製品ライフサイクル全般)
    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -072024-39177 Posted: 2024-09-11

    Global Business Management/Budget Control (Med Device) | グローバル 事業管理・計数管理(医療機器)

    医療機器業界での事業管理経験が活かせます
    7 - 11 million yen Tokyo Medical Device Business Development

    Company overview
    The company is a Japanese optical equipment manufacturer. It engages in the development, manufacturing, and sales of precision measurement equipment. Operating in various fields such as construction, agriculture, and healthcare, it provides surveying equipment and location-based technology. Particularly in the construction industry, it offers automatic control technology for construction machinery and surveying/geospatial information systems to support efficient construction operations. In the agricultural sector, it provides equipment for automatic control of agricultural machinery and devices for precision agriculture, contributing to increased productivity and environmentally conscious farming practices. Furthermore, it develops and provides medical equipment and technology, contributing to the realization of advanced healthcare.
    Responsibilities
    予算編成、計画、分析活動などの計数管理および事業管理業務を担い、グローバルに活躍頂ける方を募集致します。※将来的には、本人の希望も勘案し海外駐在も可能業務内容:
    アイケア事業全体の事業管理のサポート
    その他、業務委託契約管理、各種計数対応、部門取り纏め事項対応、所管関係会社への事務連絡・調整事項等
    上記業務内容において発生する国内外販社・機能とのコミュニケーションや協働
    サポート対象:連結・販社別の予算・見込・実績に関わる集計・分析・集約、経営層への報告、資料作成など
    Takahisa Hitotsumatsu
    Takahisa Hitotsumatsu
    Medical Device
  • Job number: JN -072024-18380 Posted: 2024-09-11

    Clinical Lead

    World\'s number 1 Ophthalmology company
    10 - 14 million yen Tokyo Medical Device Clinical Trials / Clinical Development

    Company overview
    We are a leading ophthalmic care company. We focus on the development and marketing of products and services that support eye health, including contact lenses and ophthalmic surgical instruments for improving vision and eye care. With a focus on innovation, we aim to solve vision-related problems and improve the quality of life by providing high-quality, safe products. We are also committed to social action programs and sustainable business models.
    Responsibilities
    開発戦略の作成・立案
    国内臨床試験計画の作成及び実施(プロトコール作成、総括報告書作成、CROマネジメント)
    海外臨床試験データの評価(効能効果、適応疾患などの観点から)
    承認申請資料の作成、承認申請後の対応(PMDA照会事項への回答作成等)
    PMDA適合性調査の準備
    PMDA対面助言相談の実施
    臨床研究の実施 (プロトコール作成からデータベース固定まで)
    Linh Do
    Linh Do
    Medical Device
  • Job number: JN -072024-13251 Posted: 2024-09-11

    RA Specialist (domestic and Europe)

    Japanese multinational IVD maker
    6 - 9 million yen Tokyo Medical Device Regulatory Affairs (RA)

    Company overview
    We are engaged in the medical field, specializing in clinical diagnostics. As a leading company in the industry, we provide valuable technologies and biomarker products. Our mission is to create new value in the healthcare market and contribute to the future of health and medicine. Since successfully commercializing products such as the syphilis test kit "Syphilis HA Antigen (TPHA)," we have been involved in research, development, manufacturing, and marketing, bringing innovation to the global clinical diagnostics industry. Particularly as a leading company in the field of immune sera, we have significantly contributed to medical advancement through the development of highly sensitive automated immunoassay instruments and dedicated reagents, as well as the development of rapid immunodiagnostic kits. We have garnered worldwide attention by swiftly succeeding in the development of a rapid antigen test kit for the novel coronavirus (SARS-CoV-2), demonstrating our commitment to providing highly socially impactful and necessary products.
    Responsibilities
    体外診断用医薬品・医療機器の薬事申請業務
    業許可関連登録管理業務
    薬事関連規制情報収集
    その他法規制対応

    Linh Do
    Linh Do
    Medical Device
  • Job number: JN -072024-23632 Posted: 2024-09-11

    医療製品開発のプロジェクトリーダー

    グローバルヘルステックメーカー
    8 - 17 million yen Tokyo Medical Device Clinical Trials / Clinical Development

    Company overview
    We specialize in the development, manufacturing, and distribution of medical and scientific equipment. We are particularly renowned for our expertise in fields such as endoscopy and digital camera technology. We prioritize quality and innovation in our products, playing a crucial role in the medical and research sectors. Furthermore, we tailor solutions to meet the needs of our customers, providing support to medical and research institutions worldwide.
    Responsibilities
    同社の医療製品開発プロジェクトにおいて、QCD目標達成に責任を持つ、「プロジェクトリーダー」をお任せします。
    ご担当いただくプロジェクトはご経験に応じて決定いたします。
    ■本ポジションのミッション:
    医療製品開発のプロジェクトマネージメント

    ■仕事内容:
    各部門からアサインされたプロジェクトメンバーをマネージメントしながら、担当製品の目標QCDを確保、新製品開発プロジェクトの立ち上げ~完了に責任を持っていただきます。
    Shotaro Tsubaki
    Shotaro Tsubaki
    Medical Device
  • Job number: JN -072024-33523 Posted: 2024-09-11

    Safety Specialist

    理系卒未経験の方歓迎
    6 - 10 million yen Tokyo Medical Device Quality Assurance / Quality Control

    Company overview
    Our client is the global technology leader in minimally invasive surgery.
    Responsibilities
    Manage and implement required actions to maintain existing product lines and to solve any product quality issues occurred in Japanese market. Take timely and appropriate quality management actions and executing communications with government and internal / external customers. This position has mainly following responsibilities and authorities to timely deliver effective and safety products in Japanese market, to reduce customer complaint/malfunction, and to improve product quality:
    Main responsibilities:
    Lead risk management team and implement risk management activities from the viewpoint of product and subcontractors / suppliers in cooperation with related functions.
    Assess change notifications from headquarters and manufacturing sites, and implement necessary actions in cooperation with related functions.
    Evaluate customer complaints from the viewpoint of product quality, report to company and manufacturing sites, and evaluate the analysis result in cooperation with Safety Control team. Furthermore, create customer letters, and communicate to customers to solve the quality issue with Marketing, Sales, Field Service and Safety Control teams.
    Completing quality issues by working with regulatory agencies, customers and related functions.
    Collaborate with Product Quality team and Safety Control team to reduce customer complaints from the viewpoint of product.
    Involve in implementation of a field action like a recall.
    Collaborate with QRC team to maintain Quality Management System.
    Work related to product realization (control DMRs and materials for released products etc.)
    Operate product release (IQC, labeling instructions, and market release assessment etc.)
    Manage non conforming products (rework, concession, and hold etc.)
    Work related to data analysis and CAPA.
    Shotaro Tsubaki
    Shotaro Tsubaki
    Medical Device
  • Job number: JN -072024-34256 Posted: 2024-09-11

    Installation Program Manager (Asia) | インストールプログラムマネージャー(アジア)

    Ensure smooth integration of new surgical robot in hospitals
    10 - 15 million yen Tokyo Medical Device Production Management

    Company overview
    Our client is a world leading medical device manufacturer.
    Responsibilities
    The Asia Installation Program Manager will be a key member of the Global Commercial Enablement team in the Robotic Surgical Technologies BU working to drive installations of the product.
    You will be a part of a global network of installation managers who will establish together the best practices for product installations within company and while our product footprint expands globally and in your region, you will be an active member in our country expansion programs as an OTC (order to cash) representative. Main responsibilities:
    Meet with the Sales teams weekly to review the pipeline
    Participate in the Asia sales funnel review process
    Coordinate with Field Service to perform pre-sale site inspection and track resolution of any findings that would preclude a sale.
    Determine any pre-sale simulator support requirements
    Obtain assignment of a Startup Specialist to the account
    Ensure the account places an order for consumables to support initial use of the system.
    Arrange the details of the commissioning including tracking the shipment, notifying Sales, Field Service and the Startup Specialist
    Coordinate any special requests from the account relative to commissioning
    Maintain metrics and dashboards for process control and transparent communications.
    Support the Commercial Enablement team in project related activities (commercial expansions into new countries and/or optimization projects)

    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -082024-171206 Posted: 2024-09-11

    Market Access Specialist

    World\'s leading life science solutions company
    6.5 - 8.5 million yen Tokyo Medical Device Market Access / HEOR / Reimbursement

    Company overview
    We are a leading biotech company in the healthcare industry, attracting attention for our excellence. We specialize in diagnostic pharmaceuticals and equipment, taking charge of the diagnostic segment within our group. As one of the pillars of our operations, we focus on providing high-quality and accurate diagnostic products for a wide range of diseases, including cancer, cardiovascular diseases, and infectious diseases.
    Responsibilities
    多岐にわたる弊社製品の国内導入にあたって、臨床医学・医療制度・ビジネスの観点を踏まえ、患者アクセスを最大化することを目的として、以下の業務を行っていただきます。
    業務内容:
    関係部署と連携し、製品の出口戦略を立案します。
    保険者・自治体等のペイヤーに対して、新たなサービスモデルを提案し、実現に向けた戦略を立案し、関係者と調整を行います。
    新規製品の国内導入について、保険適用戦略を含め検討します。
    Global / Asia Pacificのマーケットアクセス&ポリシーチームと連携し、国内導入戦略を立案します。
    上市後の製品について、学会や自治体等と連携し、新たな有用性を模索します。
    政策トレンドを分析した上で、内外の必要なステークホルダーと連携し、企業目標を達成するための活動に貢献します。
    学会や業界団体等と連携し、医療制度の見直しを提案します

    Linh Do
    Linh Do
    Medical Device
  • Job number: JN -072024-21702 Posted: 2024-09-11

    Software Account Sales

    Japan\'s & world\'s largest 3D print maker
    5.5 - 8 million yen Tokyo Medical Device Sales

    Company overview
    We provide and support 3D printing technology in Japan. In particular, we focus on developing 3D printing solutions for the medical and industrial fields. We utilize advanced software and precision printing technology to support the production of customized products and components. In the medical field, we have earned a reputation for producing surgical guides and implants that improve patient outcomes. In the industrial field, we contribute to the rapid fabrication of prototypes and the efficiency of manufacturing processes. By providing technological innovations and services that meet customer needs, we are contributing to the spread of 3D printing in various fields.
    Responsibilities
    医用画像処理編集ソフトウエア セールス (Mimics Innovation Suite 等)
    医療3Dプリンティングソリューションセールス(医用画像編集ソフトウエア×エンジニアリングサービス×3Dプリンティングサービス)
    学会、ユーザー会、展示会等のアテンド
    Linh Do
    Linh Do
    Medical Device
  • Job number: JN -072024-20802 Posted: 2024-09-11

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

    Global pioneer in healthcare seeks seasoned RA specialist
    7 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)

    Company overview
    We specialize in the development and marketing of medical devices. We provide advanced medical devices used primarily in the fields of cardiovascular, urology, and gastroenterology to assist in the treatment and diagnosis of patients. With an emphasis on innovative technology and research and development, we are continuously introducing products to the market that meet the needs of the medical field. Our product lineup includes catheters, stents, and endoscopic devices that boast high quality and safety. Through collaboration with medical experts, we also aim to promote effective therapies and improve medical technology. With a mission to improve the quality of life of patients, we leverage our global network to provide superior solutions to medical institutions around the world.
    Responsibilities
    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.
    Linh Do
    Linh Do
    Medical Device
  • Job number: JN -072024-149301 Posted: 2024-09-11

    Project Manager | プロジェクトマネージャー

    上市済のAI医療製品のプロジェクトマネージャー・社会的貢献度が高い業界
    5 - 9 million yen Tokyo Medical Device Production Management

    Company overview
    Our client is a med-tech venture with a strong focus on image analysis in the life sciences industry. Through the fusion of image analysis and AI technology across domains like healthcare, pharmaceuticals, and agriculture, it creates highly accurate imaging software, making substantial contributions to society.
    Responsibilities
    営業本部サイエンス事業開発グループにてプロジェクトマネージャーとして従事いただきます。
    業務内容:
    製薬企業・医療機器企業との協業(共同研究・委受託研究など)のプロジェクトマネジメント
    当社のAI技術を活用した協業案件のデリバリー各案件のロードマップ策定、進捗管理、期待値調整 等
    契約交渉

    プロジェクトに関わる社内外のステークホルダーとのコミュニケーション
    案件の拡大、横展開など事業拡大の推進自社内の研究開発企画、自社サービス企画等を含む

    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -082024-174138 Posted: 2024-09-11

    【東京】Director, Regulatory Affairs

    医療機器業界における薬事業務経験者必見です!
    13 - 20 million yen Tokyo Medical Device Regulatory Affairs (RA)

    Company overview
    We specialize in the development, manufacturing, and distribution of medical and scientific equipment. We are particularly renowned for our expertise in fields such as endoscopy and digital camera technology. We prioritize quality and innovation in our products, playing a crucial role in the medical and research sectors. Furthermore, we tailor solutions to meet the needs of our customers, providing support to medical and research institutions worldwide.
    Responsibilities
    【変更の範囲:会社の定める業務】
    The Executive Director Regulatory Affairs is responsible for leading the development and execution of the global regulatory strategy for new product development and sustaining projects, the management of all regulatory activities in support of the business units, maintaining product registrations globally throughout product lifecycles.
    The position is responsible for developing and executing regulatory strategies to support corporate growth objectives for the business by providing guidance, strategy and management of regulatory activities needed for domestic and international expansion.
    The position requires strategic partnership with the cross functional business leaders for the strategy of introducing new devices to global markets.
    This role requires interaction with global regulatory agencies and notified bodies.
    Shotaro Tsubaki
    Shotaro Tsubaki
    Medical Device
  • Job number: JN -082024-172324 Posted: 2024-09-11

    営業部長/事業戦略の策定・販売戦略の推進等

    土日祝休み/フレックス/在宅勤務可長期就労可能な安定環境
    10 - 12 million yen Kanagawa Medical Device Sales

    Company overview
    Our client is a leading global supplier in the fields of life sciences and clinical research from Europe.
    Responsibilities
    ■業務内容:
    セールスディレクターとして、売上への責任、戦略立案および実行、市場分析、人員の採用と育成を担っていただきます。


    【変更の範囲:会社の定める業務】

    ■具体的な業務内容:
    営業予算、売上や利益予測の達成を確保するため、ビジネスの戦略計画を準備、実施
    マーケティングプログラムや新製品導入による売上の成長を推進
    営業チームを指導し、目標達成を促進
    主要顧客や販売代理店、関係機関とのコミュニケーション強化
    重要なイベントの財務影響を監視し、対策を立案
    業界や競合情報を把握し、社内関係者に報告、協議する
    プロセス改善によるコスト効率向上
    優秀な従業員の採用や育成により組織強化
    顧客志向、結果重視の文化を醸成
    各種カンファレンス、トレードショー、シンポジウムなどのイベントへの代表参加
    顧客クレーム対応や既存、新規アカウントサービス提供
    設備や資材の維持管理
    指示された重要タスク処理や変化への生産的対応
    安全、品質、規制に従う


     
    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -082024-172205 Posted: 2024-09-11

    Product Manager

    整形領域のプロダクトマーケティング
    7 - 10 million yen Tokyo Medical Device Production Management

    Company overview
    We offer a wide range of medical equipment including orthopedic, neurosurgical, emergency medical, and operating room products. These include, among others, artificial joints, implants for bone fracture treatment, endoscopes, surgical instruments, and automated cardiac massage systems. Focusing on customer needs, the company strives to improve the quality of medical care through innovative products. We also continue to maintain a "rewarding work environment" by focusing on employee growth and improving the work environment.
    Responsibilities
    Main responsibilities:
    Prepare marketing plans for specified aspects/components of its products, focusing on appropriate target audiences.
    Ensure field staff receive appropriate training to achieve effective delivery of key selling messages
    Establish relationship with the U.S. Marketing Department and APAC team
    Prepare reports on request and forward any territory information regarding company products in the most appropriate way
    Cooperate closely with Logistics department for quarterly safety stock review
    Organize & perform workshops, deliver presentations and demonstrations
    Supporting sales team to improve technical knowledge about the product and documentation.
    Budgetary management for all marketing activities initiated
    Attract and retain quality employees with the best skills and qualifications to ensure that the company standards and values are met and exceeded
    Continuous development of relevant skills and knowledge
    Support development and implementation of the company quality system
    Lead the team efficiently to optimize outcomes consistent with the company’s code of conduct
    Closely work with RA/QA officers for registration documentations.
    Obtain market intelligence on local product development and competitor activities
    Contribute in the identification of KOLs and lead the communication with them.
    Support the salesforce by attending demonstrations, KOL visits.
    Cooperate closely with Logistics department for quarterly safety stock review
    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -072024-38982 Posted: 2024-09-11

    General Manager | 総括マネージャー

    Gloabl life science & diagnostics company
    11.5 - 13 million yen Tokyo Medical Device Quality Assurance / Quality Control

    Company overview
    We are a leading biotech company in the healthcare industry, attracting attention for our excellence. We specialize in diagnostic pharmaceuticals and equipment, taking charge of the diagnostic segment within our group. As one of the pillars of our operations, we focus on providing high-quality and accurate diagnostic products for a wide range of diseases, including cancer, cardiovascular diseases, and infectious diseases.
    Responsibilities
    QMS省令に基づく総括製造販売責任者業務、およびクオリティーマネジメントグループのマネジャーとして業務いただきます。詳細は以下の通り。
    業務内容:
    品質保証・安全管理業務の統括、チーム管理及びメンバー育成安全管理業務に対する総括製造販売責任者としてのアドバイス、確認、および承認
    製品への出荷可否判定にかかわる業務の監督
    苦情、品質不良などの所要措置の決定および実施
    各製造所(外国製造所を含む)の製造管理・品質管理にかかわる業務
    国内業許可管理業務の監督
    化学物質関連規制や海外HQ要求事項の国内対応の監督
    規制当局や海外HQの監査対応、および内部監査、教育訓練、管理監督者照査の実施
    海外HQとのコミュニケーション(QMS関連対応、化学物質関連規制対応、品質問題対応など)

    QMS省令に基づく総括製造販売責任者業務、およびクオリティーマネジメントグループのマネジャーとして業務いただきます。詳細は以下の通り。品質保証・安全管理業務の統括、チーム管理及びメンバー育成
    安全管理業務に対する総括製造販売責任者としてのアドバイス、確認、および承認
    製品への出荷可否判定にかかわる業務の監督
    苦情、品質不良などの所要措置の決定および実施
    各製造所(外国製造所を含む)の製造管理・品質管理にかかわる業務
    国内業許可管理業務の監督
    化学物質関連規制や海外HQ要求事項の国内対応の監督
    規制当局や海外HQの監査対応、および内部監査、教育訓練、管理監督者照査の実施
    海外HQとのコミュニケーション(QMS関連対応、化学物質関連規制対応、品質問題対応など)

    Linh Do
    Linh Do
    Medical Device
45678

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