• NEW

  Job number: JN -082025-193112 Posted: 2025-08-26

  Sales Operations Leader

  新設の役割、裁量大

  10 - 15 million yen Tokyo Medical Device Sales

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  Company overview

  Our client is a scientific business.

  Responsibilities

  Main responsibilities:
  Within the Japan region:
  Analyze and improve sales processes, optimize sales models, and support the implementation and use of sales tools.
  
  Bridge with global:
  Develop global strategies, report on sales progress, including order forecasts and pipeline evaluations, and lead global meetings.
  * While major strategies originate globally, it is important to be able to localize and devise them for Japan.
  * In the future, you will also be expected to take on pricing roles.
  
  

  

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  Job number: JN -082025-193113 Posted: 2025-08-26

  Marketing Manager (DX/VR)

  多才な人材が活躍するグローバルな環境／個々の違いを個性と捉えるコーポレートカルチャー

  7 - 10 million yen Tokyo Medical Device Marketing

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  Company overview

  A global animal health company dedicated to supporting customers and their businesses in ever better ways.

  Responsibilities

  Work as a marketing lead to achieve sales targets for the Diagnostics Division and Communication Service Division.
  Main responsibilities:
  Develop short-term, mid- to long-term business plans and marketing strategies for diagnostic products and Communication Services.
  Analyze the market and competitors, set goals and KPIs, and lead the achievement of those goals.
  Contribute to the formulation of budgets and OPEX plans for the assigned area, develop action plans and campaigns, and lead their implementation to achieve budget targets.
  Efficiently manage sales tracking, demand planning, inventory management (SAP input), PL, ASP (Actual Selling Price), and OPEX in your assigned area, and manage KPIs.
  Develop customer communication and promotion plans. Collaborate with the L&D (Learning & Development) team and CABU Sales Manager to contribute to the effective execution of communication between DSS (Diagnostic Sales) and ASR (Animal Sales).
  Develop and implement mid- to long-term marketing strategies and lifecycle plans (product launch plans, development, branding, and end-of-sale plans) in line with company-wide policies. Also create business cases and manage product liability.
  Collaborate with many related stakeholders (CABU Sales Department, CABU Technical Services Department, and development drug development department) to ensure smooth business progress and identify and overcome challenges and opportunities.
  Collaborate with each department (Post-Marketing Pharmaceutical Affairs, Quality Control, Customer Support, Supply Team, Global Team, etc.) in a timely manner and manage the planning, execution, and promotion of projects.
  In order to achieve budgets and carry out actions, you will communicate and collaborate smoothly with external KOLs (Key Opinion Leaders) to plan and execute projects.
  Participate in regular meetings with the global team in your area of responsibility, contribute to strategic alliances and securing necessary resources, and increase Japan's presence.
  Develop marketing strategies for new diagnostic products, manage projects, and ensure successful launch (achieve goals).
  The balance of work between the diagnostic and Communication Service areas of responsibility may change depending on the situation.
  Report to the Senior Marketing Director/Communication Service Business Manager as appropriate and requested, and provide support to ensure smooth business operations.
  At the core of the strategy is collaboration and teamwork with members of the diagnostics sales team, customer support team, and animal health department, contributing to the success of the entire diagnostics business.
  
  

  

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  Job number: JN -072025-192049 Posted: 2025-08-26

  Marketing Manager APAC

  【東京】日本での伸びしろのある治療機器領域

  10 - 16 million yen Tokyo Medical Device Marketing

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  Company overview

  Our client is a world leading medical device manufacturer.

  Responsibilities

  Key Responsibilities:Strategic insights:
  Develop and implement customer-centric marketing strategies for the APAC region.
  Identify regional trends, customer needs, and competitive landscape to inform strategy.
  Customer Engagement:
  Build and maintain strong relationships with key customers, healthcare providers, and stakeholders.
  Marketing Campaigns:
  Manage targeted marketing campaigns to support product launches and customer retention.
  Ensure campaigns are culturally relevant and resonate with diverse APAC audiences.
  Collaboration & Communication:
  Partner with sales, product, and regional teams to align marketing initiatives with business goals.
  Serve as the liaison between customers and internal teams to ensure feedback is integrated into strategies.
  Performance Measurement:
  Monitor and analyze campaign effectiveness, using metrics to optimize future efforts.
  Prepare regular reports showcasing outcomes and ROI.
  
  
  
  

  

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  Job number: JN -082025-193174 Posted: 2025-08-26

  Strategic Program Manager

  事業横断プロジェクト

  6 - 10 million yen Tokyo Medical Device Marketing

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  Company overview

  Our client is a world leading medical device manufacturer.

  Responsibilities

  Ultimately this role plays the key role in leading OUs and functions both from strategic programs and EA businesses and in maximizing business potential.
  Main responsibilities:
  Supporting senior manager to execute strategies by…Defining its values which resolves customers’ pain points and enables customers’ successes.
  Defining its benefits which motivate OUs and functions to work on strategic program and EA businesses.
  Enabling business transformation by leading internal stakeholders’ changes with OU/function leaders and senior manager within EA&S.
  Establishing customer C-level relationship to elevate relationship from product vendor to strategic partner.
  Developing strategic partnerships with EAs, which enables long-term mutual business benefits.
  Developing business plans for each EA to grow / protect its businesses and materialize strategic partnerships.
  Architecting partnership programs for each EA and managing all the internal and external stakeholders and processes in offer phase toward contract signature with EA.
  Managing all the internal and external stakeholders and resources throughout the partnerships. (EA’s sign-off)
  Developing Beyond Product Solutions as the enabler to address customers’ pain points, enhance strategic customer partnerships and accelerate its revenues.
  Implementing Beyond Product Solutions in targeted EAs as the real-world case to optimize customers’ daily operations as the strategic partner.
  Summarizing the effectiveness of Beyond Product Solutions as the proof points to improve customers’ financial outcomes as the strategic partner and replicate the successes in other EAs.
  Developing EA business review model for both internal and external customers with templates facilitating discussions to drive EA businesses.
  Developing EA business reporting model for JLT/GR LT to have better transparency in EA businesses.
  Developing efficient and sustainable EA offer and service delivery operations in collaboration with OUs and functions.
  Summarizing best practices as local proof points with principal commercial analyst to replicate EA successes for Other EAs.
  Leading workstreams across various functions and OUs to respond urgent requests with an impact on EA businesses and sales performances.
  Implementing continual process improvement and standardization and supporting ad-hoc reporting requests flexibly.
  
  

  

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  Job number: JN -042025-187462 Posted: 2025-08-26

  Acute Care Marketing (Manager)

  大手医療機器メーカーのマーケティングマネージャー

  12 - 16 million yen Tokyo Medical Device Marketing

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  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:
  Author and leverage marketing team to create key strategy documents: strategic plan, annual marketing plan, product launch plans, etc
  Surface new or unexpressed customer needs, leading to product/program improvements
  Adhere to organizational protocols, practices and procedures for gathering competitive information
  Drive segmentation and targeting methods to improve commercial efficiency
  Develop pricing approach consistent with the marketing strategy and brand positioning
  Accurately forecast resource needs
  Establish metrics and goals/success criteria and milestones
  Demonstrate financial acumen
  Hold self and others accountable to deliver high quality results with passion, energy, and drive to meet business priorities
  Mentor, develop and inspire others
  Collaborate and influence others on cross-functional teams, advancing partnerships to achieve business objectives
  Develop key relationships with industry/market thought leaders, organizations, and institutions, in collaboration with other marketing leaders
  

  

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  Job number: JN -082025-193175 Posted: 2025-08-26

  Senior Product Manager, Data Solutions

  【東京】売り先の幅が広い医療機器のマーケティング

  6 - 9 million yen Tokyo Medical Device Marketing

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  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

  ■マーケティング戦略・市場対応-Data Solutions製品に関するマーケティング戦略の企画・実行-市場動向や競合分析を通じて戦略を立案し、適切な施策に反映-協業すべきパートナー企業の特定とアライアンス推進-顧客の声（VoC）やトライアル結果をもとに、本社（米国）と連携し製品改善を提案・交渉-Key Opinion Leader（KOL）との関係構築・連携強化-販促資料（パンフレット、カタログ、プレゼン資料など）の作成-営業・マーケティングチームへの製品トレーニング実施
  ■技術・導入支援-技術的知見（サイバーセキュリティ含む）を活かした営業支援-米国本社や国内関係部署と連携し、製品のサイバーセキュリティ対応を推進-Data Solutions製品導入におけるプロジェクトマネジメント全般-導入準備作業（アカウント登録、マスタ設定など）の実施-顧客先での導入支援および立ち上げフォロー-導入プロセスの設計および最適化-導入手順書や関連ドキュメントの作成と整備
  

  

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  Job number: JN -082025-193149 Posted: 2025-08-26

  代理店営業

  ビジネス英語の使用経験がある方（目安：TOEIC700点）必見です

  6.49 - 7.3 million yen Tokyo Medical Device Sales

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  Company overview

  Our Client is a manufacturer of medical scientific instruments and medical equipment.

  Responsibilities

  各エリア外資代理店へ、市場動向やニーズに沿った製品/価格変更など、効果的な企画・提案を行います。
  

  

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  Job number: JN -062025-189372 Posted: 2025-08-26

  National Sales Director ｜ Medical Device

  Lead, manage, and coordinate CP strategy for Japan

  15 - 19 million yen Tokyo Medical Device Sales

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  Company overview

  Our client is medical device manufacturer based in Europe.

  Responsibilities

  
  The international company is seeking a Japan Sales Head for a medical device manufacturer.
  They are looking for Highly skilled and experienced professional who can oversee the sales of our core business, the artificial heart-lung division, and who can potentially succeed the current President of the Japan subsidiary.
  Although they are a mid-sized company that operates through distributor sales, they hold a high market share in distinctive fields such as artificial heart-lung machines, artificial lungs, heart-lung circuits, autologous blood recovery devices, blood filters, extracorporeal circulation cannulae, and other cardiac surgery-related medical devices.
  Many of our leadership members, including the President, have backgrounds in major corporations, creating a high-literacy corporate culture that is very attractive.
  This position involves working closely with global partners and engaging in negotiations to drive our business forward.
  ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
  The National CP Sales Director leads, manages, coordinates the CP strategy for Japan and contributes to the success of the CP business in Japan.
  The National CP Sales Director has the strategic vision on how to develop the CP business in Japan and, at the same time, is focused on execution to realize its strategic vision.
  ■Main responsibilities:
  Achieve all Japan CP sales objectives: orders, revenue, contribution margin, customer satisfaction & retention while staying within allocated base cost budget
  Understand and analyze market dynamics and competition to develop business opportunities.
  Provide on‐going feedback to management
  Successfully manage and collaborate with internal stakeholders both from Sales/Marketing & Operations to develop sales growth strategy and the execution plan to ensure short term and long term growth continuously
  Translate strategy and business plan into actions that can be tracked, measured and adjust actions timely to be competitive in the market.
  Build/Manage strong relationships with customers’ decision makers/management/KOLs and support sales team to win the opportunity
  Build/Manage strong relationships with distributors’ management and support sales teams’ negotiation/business discussions with distributors
  Support organizational development through an inclusive approach, being able to lead the existing local sales team to achieve stretched targets. Strong focus on first line managers’ development and engagement of the team
  Act as a primary CP customer point of contact and represent the company
  Promote, identify and escalate commercial service needs
  Attract, retain, train, and develop top talents
  Follow company policies, procedures and operating mechanisms
  Demonstrate unbending ethical behavior and instill a strong compliance throughout the organization by systems and walking the talk, ensuring knowledge of compliance and its company policies
  
  ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━#featuredjob5

  

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  Job number: JN -082025-193056 Posted: 2025-08-25

  【平塚】QA　国内外製造所管理（第二グループ）

  ～福利厚生充実／国内トップクラスの製薬メーカー～

  6 - 10 million yen Kanagawa Medical Device Quality Assurance / Quality Control

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  Company overview

  Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.

  Responsibilities

  ■業務内容：国内外に展開される商用医薬品・治験薬における品質マネジメント推進
  製造委託先管理業務としての品質課題対応/変更管理/逸脱/品質情報/品質契約等の対応並びにGMP向上のサポート
  海外当局査察にむけた Inspection Readiness の推進・製造所の支援
  当局提出資料(IND/IMPD、CTD、承認申請書、試験報告書等)の信頼性の確保(文書監査)
  海外グループ会社を含めた社内関係各部所と連携し、製品(治験薬及び商用医薬品)安定供給の推進
  製造所等のGMP/GDP監査
  経験の浅いメンバーのサポート
  
  ■募集背景：商用医薬品・治験薬の製造委託先における委託品目管理の中心人物として、製品の品質を支える重要な役割を担っていただきます。
  海外のグループ会社、製造委託先等との協業が主業務となり、関係者を巻き込みながらグローバルに活躍していただきます。
  
  ■キャリアパス：同社グループのグローバル製品品質保証に最も重要な製造所管理を推進・統括する中核的人材へと育成する。
  適正・経験を踏まえ、品質マネジメントシステムの構築・維持・改善に参画いただく可能性がある。
  その後、当人の適性を踏まえたジョブローテーションを通じて、幅広い業務経験を積み、キャリアを形成し、経営基幹職或いはマネジメント職の登用を視野に入れた育成を行う。
  
  

  

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  Job number: JN -082025-193055 Posted: 2025-08-25

  【東京／本社】薬事申請＜海外薬事＞◇プライム上場医療機器メーカー兼商社／安定性◎／年休124日

  医療機器の薬事または開発関連業務のご経験をお持ちの方へ

  7 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)

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  Company overview

  Our client imports and sells medical equipment.

  Responsibilities

  【医療機器の薬事または開発関連業務のご経験をお持ちの方へ／英語力を活かせる／循環器領域を専門とする独立系の医療機器商社×メーカー／国内シェアトップクラスの製品を保有】
  ■業務内容：当社が製造販売する製品の海外許認可取得のための申請、及びその支援業務を行っていただきます。グローバルコミュニケーションが必要で、R&D、QA、工場、及び海外企業と連携しながら業務を遂行いただきます。
  
  ■業務詳細：海外薬事申請、及びその支援業務（必要資料の作成、編纂及び提供）を担当します。
  関連部署との協議、進捗管理もご担当いただきます。
  担当製品としては心臓疾患治療用の機器が主になります。
  
  ■キャリアパスについて：将来の責任者候補としての活躍を期待しています。また、社内他部署への異動希望を出せる制度もあります。
  
  

  

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  Job number: JN -082025-192351 Posted: 2025-08-22

  糖尿病事業部　コアプロダクトマーケティング（海外）

  B to C領域も経験できます！

  6 - 8 million yen Tokyo Medical Device Marketing

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  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

  業務内容：
  マーケティング調査・分析に基づく成長戦略立案。
  グローバル市場をスコープとした販売体制強化のための提携交渉、海外拠点の組織構造改革の推進。
  新商品企画プロジェクトにおいて、開発・薬事・臨床開発・デザイン・品質保証・ 提携先・海外拠点など様々なステークホルダーを取りまとめながら、マーケティング戦略のインプリメンテーションとプロジェクトマネジメントを実行。
  特に中国・東南アジアの成長機会を捉えるため、医療機関攻略だけでなく、リテール（ＯＴＣ）向けのマーケティング・プロモーション戦略の立案と実行力があることが望まれる。
  
  

  

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  Job number: JN -072025-191155 Posted: 2025-08-22

  Sales Representative

  【横浜】測定機器等の技術営業

  6 - 12 million yen Tokyo Medical Device Sales

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  Company overview

  We are a leading scientific services provider, offering import/export, sales, and maintenance services for analytical and other equipment. Through products like reagents and software, we support researchers and contributes to scientific advancement. Particularly addressing needs in fields like scientific research, healthcare, and pharmaceuticals, we enhance research and medical practices. With a diverse product lineup, we meet customer needs while providing innovative solutions. Additionally, we offer customer support such as technical assistance and training programs, fostering long-term partnerships.

  Responsibilities

  研究開発及び物性評価機器営業担当
  ポジションの魅力
  製薬業界・自動車業界・大学・ポリマー業界など非常に多様な業界を担当することで、幅広い経験や知識を身につけていただくことが可能です。また、日本は成長が大きく期待される市場として特に成長機会が多いマーケットです。
  職務の内容: Responsibilities
  事業部の扱う複数の分析機器について見込顧客および既存顧客への販売活動を実施する。
  既存顧客、見込顧客が抱える課題やニーズに対し、製品群を通じてソリューションを提案する。
  営業同士、アプリケーション（技術サポート）スタッフやサービス部門とコミュニケーションをはかりながら業務連携し、製品だけでなく組織としての価値を最大限に発揮して顧客からの信頼を得る。
  顧客の要求や競合の状況などを把握し、市場の状況を踏まえ戦略を立てながら販売活動を実行する。結果を振り返り改善しながら、より良い営業活動を行う。
  顧客とのミーティングやワークショップ、セミナー講義等を、アプリケーションスタッフと連携して実行する。また、営業促進ツールのコンテンツ作成をマーケティング、アプリケーション、サービス部門と連携して行う。
  展示会や学会へ参加し、当社の掲げる価値を提案する。
  営業やフィールドサービス部門と密に連携を図り、部門や製品の垣根を越えて顧客にこの上なく満足いただけるよう努める。
  英語力がある場合は、ドイツの工場とのコミュニケーションやTraining参加などの機会もあり
  トレーニング、学習の機会を十分に提供します
  
  

  

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  Job number: JN -082025-193050 Posted: 2025-08-22

  Senior Product Specialist

  【東京】手術支援ロボットのマーケティング

  7 - 10 million yen Tokyo Medical Device Marketing

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  Company overview

  Our client is a world leading medical device manufacturer.

  Responsibilities

  Upstream Marketing:Identification of upstream opportunities for market including organic and inorganic opportunity assessment
  Downstream Marketing:Identify and support market development initiatives
  Develop strategies and execute marketing plans and programs, both short-and long-term, to ensure the profitable growth and market share of the assigned portfolio.
  Information Technology Service and Data Solution Marketing:Build strategies and execute data management business including AI technologies
  Strategic Input:Voice of region within PMT
  Develop promotional strategies, sales support materials, educational aids, etc. to grow market share to ensure sales excellence.
  Oversee the development of customer satisfaction survey and needs assessment to continuously improve business models and communicate to global partners.
  Regional Ambassador:Ensure alignment to broader Surgical global strategy
  Assess and support to build/expand functional capabilities
  Conduit to regional marketers
  Department specific/Non-essential functionsOther duties as assigned with or without accommodation.
  
  
  

  

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  Job number: JN -082025-193045 Posted: 2025-08-22

  Specialist, Safety Group

  大手医療機器メーカーのGVPポジション

  6 - 8 million yen Tokyo Medical Device Marketing

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  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

  【業務内容】 安全管理責任者の指示のもと、製品出荷後の安全管理情報（品質、有効性及び安全性に関する事項その他医療機器の適正な使用のために必要な情報、製品解析結果を含む）の評価、および必要な安全確保措置の検討を行います（不具合等報告、廃棄、回収/改修、販売の停止、添付文書・取扱説明書の改訂、情報提供等）。 
  安全確保措置の実施にあたっては、社内関係者（営業部、マーケティング部、オペレーション部、薬事本部、臨床開発部及び法務本部等）、業界団体及び行政関係者と調整します。  
  安全管理情報の収集、検討及び安全確保措置の実施に必要なプロセス、手順及び管理方法を開発、確認、維持します。プロセス、⼿順及び管理方法を維持するため、苦情・安全管理情報の収集、検討結果及び措置の立案結果をレビュー、分析及びレポートし、問題解決のための是正措置を検討、立案し、実施します。 
  市販前、市販後の添付文書作成、改訂のレビューを実施します。 
  苦情・安全管理情報を海外製造元と共有します。製造元との定期会議にて本邦の現状を共有し、対策について協議します。 
  苦情製品の海外製造元への発送について関連部門と連携し、製品解析を支援します。 
  使用成績調査対象製品について、市販後安全性情報および安全確保措置の実施結果を主管部門に連携し、使用成績調査対応を支援します。 
  各種プロジェクトに参加し、プロジェクトの目標達成に貢献します。 
  
  
  

  

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• NEW

  Job number: JN -082025-192815 Posted: 2025-08-22

  技術営業（医療機器）

  老舗商社の医療機器技術営業

  6 - 9 million yen Tokyo Medical Device Service Engineer

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  Company overview

  Our client is a cutting-edge electronics trading company offering comprehensive global support. Clients include major gobal manufacturers of semiconductors and electronic components, home appliance companies, corporations, and research institutes.

  Responsibilities

  業務内容：
  医療機器の販売およびプロモーション
  販売代理店とのパートナーシップ構築
  診断用医療機器の拡販活動ハンズオン・デモを伴う製品説明の実施
  製品納入時の設置作業および操作方法・導入説明の実施
  関連学会への協賛対応（企業展示等）
  販促ツール（配布資料、ウェブページ等）の作成
  
  
  

  

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• Job number: JN -082025-192356 Posted: 2025-08-19

  セールスマーケティングチーム　プロダクトマネージャー

  医療機器業界でのマーケ経験者必須です

  6 - 8.5 million yen Tokyo Medical Device Marketing

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  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

  業務内容：
  関連商品のプロダクトマネージャーとして日本市場戦略を立案し、 販売計画達成を目指します。
  国内導入予定の商品を担当いただき、海外本社、国内関連部門と連携し、製品上市計画からプロモーションまでマネジメントを行います。
  

  

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• Job number: JN -072025-190865 Posted: 2025-08-19

  Regulatory Affairs Specialist

  高度医療機器の薬事ポジション

  6 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)

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  Company overview

  Our client is a world leading medical device manufacturer.

  Responsibilities

  業務内容：
  
  経カテーテル弁留置用デバイスやステントグラフトなどを中心とした製品のタイムリーな国内導入に向け、その製品特性、開発計画、市場およびビジネス上のニーズ、上市戦略を理解し、海外製造元および関連部署と協力して、薬事承認および保険に関する申請戦略を立案する。
  薬事申請戦略および作業計画に基づき、海外製造元および国内関連部門の協力を得て必要な情報を収集し、行政当局との相談を行いながら、質の高い申請書を効率よく作成し、審査当局に提出し、承認取得する。
  製品の変更情報に対する評価、対応
  関係部署と連携して添付文書作成、保険適用業務を行う。
  米国本社との良好な信頼関係とコミュニケーションを維持して、必要な情報をタイムリーかつ正確に取得し、薬事行政上の必要な判断や措置を遅滞なく講じる。
  国内薬事関連法令やグローバルな薬事行政の動向、担当する製品群および関連治療についての最新の情報・知識を収集する。
  販促物（カタログ等）の内容確認
  その他薬事関連業務の進行
  

  

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• Job number: JN -122024-181689 Posted: 2025-08-18

  薬事スペシャリスト（薬事品質保証業務）

  薬事申請での実務経験者必見です!

  7 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)

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  Company overview

  欧州発の医療機器メーカーです。

  Responsibilities

  医療機器の薬事申請業務全般 （対象となる医療機器のクラス：1～4） 
  製造販売承認・認証申請等業務
  -薬事申請文書の作成、申請 -資料取集（海外製造元からのデータ収集・管理、各種調整折衝 ）-PMDA・認証機関との折衝（PMDA相談、照会対応を含む） -申請に必要な規格試験等の実施 保険収載業務（保険適用希望書作成等） 
  業態の許可管理、更新申請 
  添付文書の作成並びに維持管理 
  -販促物（カタログ等）の内容確認 -安全管理業務（GVP）のサポート -その他 

  

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• Job number: JN -062025-190237 Posted: 2025-08-15

  歯科医療機器の品質保証

  医療機器における品質保証・品質管理の実務経験をお持ちの方必見です

  5 - 7 million yen Tokyo Medical Device Quality Assurance / Quality Control

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  Company overview

  We are a provider of dental products and related services. We have developed a broad product lineup in the field of dentistry to meet the needs of dentists and dental technicians. In particular, we provide diagnostic and treatment instruments and materials necessary for dental treatment, as well as products utilizing digital technology, which are highly valued for their high quality and reliability. We are also actively involved in the latest trends and innovations in the dental industry to help improve patient outcomes and advance dental care. We are committed to strengthening our partnerships with the local community and contributing to better health through education and community activities.

  Responsibilities

  同社製品の品質保証業務（歯科機器類、歯科材料、インプラント等)をお任せいたします。【具体的に】品質システム文書への展開
  国内外製造業者とQMSの有効性確認
  同社製品の品質に関する情報を収集・分析し、製品サービスに反映させる
  品質問題が生じた場合の原因解明、再発防止策の作成
  同社サービスエンジニアに対し、品質情報および技術アドバイス
  内部監査員として内部監査を計画・実行・改善事項の報告・効果確認
  【主なコミュニケーション先】本社（欧州・米州）設計、開発、品質保証、マーケティング部門担当者、同社営業部門、マーケティング、サービス部門担当者

  

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• Job number: JN -072024-18086 Posted: 2025-08-15

  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

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  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
  

  

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