Jobs list of Medical Device

Quality Assurance Specialist (Product Quality)

Advance robotic-assisted surgery w/ cutting-edge innovation

6.4345 - 9 million yen Tokyo Medical Device Quality Assurance / Quality Control

Company overview: Our client is the global technology leader in minimally invasive surgery.
Responsibilities: 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 ISI 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.

【リモート可】Senior Service Commercial Manager

APACアフターサービスマネジメント／英語スキル活かせる

16 - 20 million yen Tokyo Medical Device Marketing

Company overview: Our client is a world leading medical device manufacturer.
Responsibilities: アメリカで生まれた医療機器のリーディングカンパニーの日本法人にて
【シニアサービスコマーシャルマネージャー】
を募集いたします。
同社にジョインし、ともに患者さんの生活にポジティブな影響を与えませんか？
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■ポジションについて
商業サービス戦略のリードおよび実行をご担当いただきます。
この役割には、ビジネス機会の開発、サービスセールスの最適化、医療業界に対する深い理解、および卓越した顧客体験の確保において強力なリーダーシップが求められます。
■Responsibilities
Develop and execute strategic plans to grow the service business, identify new opportunities, and expand into new markets, aligned with company goals.
Lead, manage, and motivate direct/indirect service sales teams, achieving targets for revenue, and contract capture rate.
Collaborate with internal stakeholders to align service offerings with customer needs and market trends.
Oversee budgeting, forecasting, and reporting for the service business unit.
Ensure compliance with company policies, industry regulations, and quality standards.
Coach and mentor team members to achieve high performance and foster a collaborative environment.

■働く環境
リモートワーク可
スーパーフレックスタイム
退職金制度や各種割引サービスなど充実した福利厚生

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Manager, Service Strategy & Operations｜サービス戦略・オペレーションマネージャー

アメリカに本社を置く医療機器・診断薬メーカー／ハイブリッド勤務可／英語スキル活かせる

10 - 15 million yen Tokyo Medical Device Service Engineer

Company overview: Our client imports and sells allergy and autoimmune diagnostic solutions.
Responsibilities: ━━━━━━━━━━━━━━━
同社はアメリカに本社を置き、世界中に125,000人の従業員を擁しています。
総売上高は440億ドル、研究開発費は15億ドルに及び、
同ブランドは、世界のさまざまな分野の基礎・応用研修、製品開発、品質管理・保証、安全保障から
医療、製薬・バイオ医薬に至るお客様に広く浸透しています。
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■ポジションについて
サービス本部の事業成果最大化に向け、フィールドサービス（FS）およびテクニカルサポート（TS）組織全体の戦略設計、オペレーション最適化、KPIマネジメントの統括をお任せします。
部門横断の連携、プロセス標準化、デジタル活用を推進し、メンバーが自立して動くための仕組みと方向性を構築することで、サービス組織の統合と長期的な成長をリードいただきます。
■具体的な業務内容
サービス組織全体のビジョン、戦略、KPI、オペレーションモデルの策定
KPIダッシュボード構築、レビュー運用の定着化、改善ロードマップ管理
FS/TS/営業/品質/SCMなど部門横断連携の設計と運営（R&R明確化）
ServiceMax、Lab Community、AI予測等を活用したオペレーション最適化の推進
プロセス標準化と業務改善の企画と実行管理
顧客満足向上戦略の設計と実行（CASレビューおよび改善）
人材育成体系（スキルマップ、育成ロードマップ、評価指標）の構築
コミュニケーション基盤の整備（共通言語、レビュー運営、文化形成）
リソース戦略とコストマネジメント、組織パフォーマンスの最適化
サービス本部長のビジネスパートナーとして課題管理と意思決定支援

■成果指標の例
サービス組織全体の KPI 可視化およびレビューサイクルの定着化
FS／TS間および関連部門との協働モデル構築と業務再現性の向上
顧客満足度向上および品質／コスト改善指標の改善
自立して動ける人材基盤（育成仕組み／スキルマップ）の構築と浸透

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【リモート可】プロダクトマーケティングスペシャリスト｜Marketing Specialist

好調コンパニオン診断事業のマーケティング職！

6 - 9 million yen Tokyo Medical Device Marketing

Company overview: Our client is a leading biotechnology provider dedicated to advancing scientific and medical research. Based in Tokyo, Japan, it plays a vital role in enhancing research across fields such as molecular medicine and forensic science.

Globally, our client operates in approximately 160 countries. The Japan branch is a key part of this network, offering cutting-edge products and services essential to life sciences labs worldwide. Its innovative instrument systems and comprehensive range of reagents support significant advancements in biotechnology.
Responsibilities: ━━━━━━━━━━━━━━━
マーケティングとして、主にがんのコンパニオン診断の既存・新規がん腫
またはバイオマーカー追加に伴う薬事承認後の市場導入戦略の立案・実行を主にご担当いただきます。
社内のレギュラトリーアフェアーズ、メディカルアフェアーズ、プログラムマネージャー、テクニカルサポート、セールス、オペレーション、広報などの様々関連部署の連携を取り、商業戦略を立案・実行していただきます。
＊様々な癌種に対象を広げるよう開発を進めているため、幅広いがん医療への貢献をダイレクトに感じることができます。＊専属セールスチームと連携してCommercial activityを加速していただきます。
■具体的な業務内容
ODxTTまたODxETをはじめとする薬事規制製品薬事承認後の市場導入戦略立案と実行
関連学会、規制当局へのロビー活動（業界団体活動）
社内のレギュラトリーアフェアーズ、メディカルアフェアーズ、プログラムマネージャー、テクニカルサポート、セールス、オペレーション、広報などの様々関連部署の連携のハブとなっての各部門へのフォロー
パートナー製薬企業や検査会社と協力し、パートナーのリソースを活用したプロモーション活動
ODxTTまたODxETの業績に責任を持ち、各がん腫における精緻な市場分析を行う
主要顧客と直接対話し、技術的および商業的ニーズを理解し、そのニーズをサーモフィッシャー社内の適切なリソースに伝え、積極的にフォローアップする

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Senior Manager, Commercial Solutions｜コマーシャルソリューションシニアマネージャー

【東京】業績成長が著しい医療機器メーカー／『働きがいのある会社』ベストカンパニーに選出

10 - 15 million yen Tokyo Medical Device Commercial Excellence / Sales Operations / SFE

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: ■医療器具・器機のメーカーにて【Commercial Solutionsシニアマネージャー】
を募集いたします■
アメリカで創業され、130年以上の歴史を持ち、
75の国・地域で展開、年間１億5000万人以上の患者さんに貢献をしてる医療機器メーカです。
◆魅力ポイント◆
2018年から2025年まで8年連続で『働きがいのある会社』ベストカンパニーに選出されています。
今年４月に本社を移転したばかり。医療の向上を目指して成長する姿を表す、大きく弧を描くおしゃれなスパイラルデザインで、明るいオフィスです！
マネジメントスキル研修やグローバル研修など成長の機会もたくさんあります。

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■Responsibilities
Responsibility and accountability for the development, delivery, implementation reporting of S.F.D.C to achieve key business objectives across Japan Commercial
Engage with relevant internal stakeholders to implement S.F.D.C functionalities to drive the business needs and support the sales strategy
Develop tailored dashboards / reports to monitor performance data and track progress ensuring they are easy to use and implement for the end user
Reinforce digital marketing and sales force leveraging the SFDC functionalities and Ai technologies for entire Japan business
Measure the activity of the sales force and monitor their results while also aligned to the needs of relevant stakeholders
Contemplate the sales strategy and territory design working with commercial leadership based on activities and market data
Adhere, without exception, to Corporate compliance and ethics policies

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Senior Clinical Research Specialist

業界トップクラスの臨床組織

6 - 10 million yen Tokyo Medical Device Clinical Trials / Clinical Development

Company overview: Our client is a world leading medical device manufacturer.
Responsibilities: 治験の安全性・信頼性を担保し、日本の規制に適合した効率的な試験運営を支えるため、以下のような業務を実施していただきます。
業務内容：
治験、市販後臨床研究および市販後調査の計画・実施・進捗管理と報告書作成
担当施設における手続き業務、モニタリングならびに監査対応
関連文書の作成および確認
内部・外部関係者との良好な関係構築
重篤有害事象や逸脱の報告と対応、および医療機器の不具合報告と対応
担当試験のモニターチームのリード (リードモニター業務)
下位あるいは低経験値モニターのティーチングならびにコーチングによる育成
その他、組織やプロジェクトに必要な業務

National Sales Director ｜ Medical Device

Lead, manage, and coordinate CP strategy for Japan

15 - 19 million yen Tokyo Medical Device Sales

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.
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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

Shotaro Tsubaki
Industrial & Life Science

内視鏡品質保証業務

日系大手医療機器メーカー内視鏡品質保証業務

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

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: 内視鏡システム製品及び関連製品の品質保証業務、および、品質管理システム(QMS)スペシャリスト内視鏡製品の製造販売業者としての品質保証業務(国内、海外)
内視鏡開発のQMSの管理運営、及び、監査・査察対応業務(MDSAP、MDR/IVDR、FDA査察、適合性調査他)

PV Manager

Pharma業界の方歓迎

10 - 13 million yen Tokyo Medical Device Quality Assurance / Quality Control

Company overview: We are the Japanese subsidiary of a leading U.S. company in the pharmaceutical and healthcare industry, offering a wide range of products. We provide high-quality and high-performance products and services that cover a broad spectrum from diagnostics to treatment, including diagnostic drugs and devices, pharmaceuticals, hospital products, and nutritional supplements. We have earned high praise for our offerings. Naturally, there is also interdepartmental mobility and information sharing, which helps us maintain our overwhelming position as a comprehensive healthcare manufacturer.
Responsibilities: Manage the collection, processing and assessment of safety related information as it relates to the company's Nutrition products in compliance with applicable regulatory requirements and guidelines, as well as division and corporate level policies and procedures; Ensure the pharmacovigilance (PV) system for the company's Nutrition products registered as drugs in Japan is in place and is compliant with regulatory standards; Maintain the PV IT system used for adverse event reporting. The manager is considered a subject matter expert in the area of pharmacovigilance.
Main responsibilities:
Manage the Japan PV team (through guidance and supervision) in the collection, review, and assessment of adverse event reports/safety related information
Ensure submission of reportable adverse events to the health authority in accordance with requirements and timeframes outlined in local regulations
Develop and maintain local standard operating procedures that are aligned with corporate/division level policies and procedures and follow local regulations
Develop and provide PV training for new/junior team members and local affiliate staff
Serve as the point of contact for all local PV activities, inquiries and issues, including responding to inquiries from the health authority
Prepare and submit periodic reports to the health authority in compliance with local regulations
Conduct internal inspections of the PV system as required by local regulations
Serve as the PV lead during internal audits and external inspections; prepare and execute CAPAs for any PV related findings
Participate in the review of promotional materials
Act as the safety database administrator, including coordinating maintenance and upgrades of the PV IT system
Manage vendor and process associated with searching of scientific literature for safety related information
Participate/collaborate with the Medical Safety & Surveillance team on global safety/pharmacovigilance related initiatives and goals
Functions independently as a decision-maker within specified parameters and decisions could potentially have financial ramifications or impact brand reputation, regulatory compliance, or patient and product safety.
Individual is recognized as an internal subject matter expert and resource with responsibilities that require high level critical thinking and analytic abilities.
Leads cross-functional projects related to the area of expertise with a high level of visibility across the local affiliate site.
Responsible for ensuring compliance with local regulatory requirements related to pharmacovigilance for Japan’s drug products.

GVP Senior Specialist/ Specialist

GVP/PVの経験（製薬・医療機器不問）が活かせます

6 - 8.5 million yen Tokyo Medical Device Quality Assurance / Quality Control

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: 【未経験チャレンジ枠もあり◎／トップクラスシェア製品の安全性管理を通じて医療の安全に貢献】
■職務内容：
医療機器（TAVI：経カテーテル大動脈弁置換術）の安全性情報に関する安全管理業務全般国内/Globalのデータベースへの情報入力（英語/日本語）：安全性情報の英訳、GVP業務
行政報告書の電子申請業務：Web による申請業務
医療現場担当者（営業他）への各種問い合わせ
GVP業務に関するGlobalの関係部門との調整
行政、業界、学会等への安全性に関する対応
各種報告書、データ作成
将来的に、以下業務に関わっていただく可能性もございます。医療機器添付文書に関する他部門との協業
GVP教育訓練の資料作成、運用
内部・外部監査の事前準備、監査員への応答
発生事象のデータ集計、トレンド分析、関連部門への提供と説明
GVP業務に関連したソフトウェアの検証試験、管理

■ポジションの魅力：
国内外でトップクラスシェアの製品の安全管理業務に携わるため、その分責任も社会的意義も大きい
承認拡大や新製品導入が継続的にあり、最新の医療技術を学び続けられる
チームメンバーや海外拠点の社員が協力的かつ穏やかで、中途入社者も安心して仲間に入って働ける雰囲気
業務の幅を拡げられるチャンスが多い
英語でのトレーニング受講や会議の参加、（ゆくゆくは海外出張）を通じて語学スキルを向上できる

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

Medical Account Sales Representative

An international leader in the fields of medical and safety

5 - 7 million yen Tokyo Medical Device Sales

Company overview: We are a foreign-affiliated manufacturer handling medical equipment and related devices. With operations in over 190 countries and development and production facilities across five continents, we are an international company. Our products are designed to meet the needs of our customers, and we invest time in understanding their requirements before product development. To ensure safety, we allocate funds to our in-house testing center and quality management, providing reliable and optimal products and solutions from automated production to custom projects.
Responsibilities: Join a leading medical device manufacturer that has been contributing to the global healthcare industry for over 130 years. They are seeking a Sales Representative who is eager to leverage their sales skills to support acute care with our diverse product portfolio and advanced technologies. Be a part of a company dedicated to enhancing medical safety and making a significant impact in healthcare settings worldwide.
Responsibilities:
Sales of ventilators, general anesthesia machines, ICU/NICU equipment, vital sign monitors, consumables & accessories, phototherapy devices, surgical shadowless lights, etc.(Main Customers: University hospitals and major general hospitals)
1. Representing company in the accounts in your assigned territory and managing the overall relationship (through CRM, Customer Relation Management)Hospital Strategic Direction (5 years)
Define decision makers and contact persons for the creation of individual units
Responsible advice to management
Monitor your account transformation
Proactive sales of Company's products and solutions
Dissemination of Company'sstrategy/philosophy
2. Establish a business plan for the account aligned with Company's Medical's structure (details below)Mid- to long-term and short-term plans, activities/products/solutions and customer implementation results (Company's and non-Company)
Short-term and long-term deal planning through CRM
Updated and analyzed won and lost orders
Monitor ROI on individual deals and marketing activities using account plans
3. Representing the account within Company'sMedicalAll coordination issues between the customer and Company (e.g. order confirmation, invoicing, delivery, product training and after-sales management requirements)
Coordination of customer requests & document and presentation requests
Demonstrations and factory tours
Finalizing and approving the contract
Order confirmation (sales work completed)
4. DemonstrationManagement of demonstrations (e.g. timing, equipment specifications)
Coordination of implementation at hospitals with appropriate application specialists
5. Communication with the marketIf necessary, provide market trends to clients in line with account plans
Update competitive information through internal Company's communications and report competitive information to Marketing via customers
Update account information in CRM (Customer Relation Management) tools, with sales and marketing providing the information.
Promote active participation in the conference and exchange of information with conference participants
Provide marketing support in coordinating with instructors within the account
6. Price reductionResponsible for profit and loss. Controls discounts and other factors to close deals (payers, promotions, etc.). Discount amounts are defined by ISO agreement.
7. Customer visitsPlan, organize and execute customer visits. Logistics are coordinated by Modality Management and concerned departments.

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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.

Head of Marketing

Lead to be Japan\'s top IVD company, the most trusted partner

11 - 19 million yen Tokyo Medical Device Marketing

Company overview: We focus on strategies that prioritize improving efficiency and quality in healthcare, while also emphasizing cost reduction. In today\'s challenging healthcare reform environment, we provide a portfolio of advanced imaging diagnostics, clinical testing, treatment systems, and IT solutions to support providers in achieving long-term success. We are dedicated to delivering personalized healthcare at affordable prices, adapting to the dynamics of healthcare to enhance both quality and efficiency. We strive to build sustainable infrastructure and work towards providing better care to more people at lower costs.
Responsibilities: They are seeking an experienced and strategic Head of Marketing to join their esteemed company, a market leader in imaging diagnostics, specializing in CT, MRI, and X-ray equipment. With a strong commitment to innovation, they invest approximately 10% of their turnover in research and development. The mission of this position is to lead the company to become the top IVD company in Japan, to be the most trusted partner for their customers, and to create the most attractive workplace in the industry. You are invited to join them in driving their vision forward and making a significant impact in the medical technology field.
Role Description:
・Responsible and accountable for business plan backed up by solid marketing plan ・Marketing excellence, launch excellence and portfolio management excellence・Business analytics, financial planing and sales force excellence・Team development to make a strong marketing team ・Commercial operation including process improvement・Marketing program and campaigns to win business・Developping anual / mid term busness plan / marketing plan (budget process of MTA/MBR) ・Driving business practically to achieve financial targets & KPI・Business case development ・Projects leads ・Organizing appropriate training and education plan ・Strategic business planning and lead business development・Acting as "think tank" for LS Japan on key business opportunities and issues
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THV Product Marketing Mgr/ Sr.Spec

マーケットの拡大を目指せるやりがいあるポジションです

7.5 - 11 million yen Tokyo Medical Device Marketing

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: This position manages exciting new product and indication expansion launches and promotion as market leader by collaborating with key opinion leaders (KOL) and Japan/global stakeholders.
Key Responsibilities
Develop comprehensive marketing launch plans including strategies and tactics for major product launches. Lead the execution of a major product launch in collaboration with regional partners as appropriate including Salesforce readiness (e.g., training on product, messaging, and competition)
Develop marketing materials and programs that support product launch and commercialization strategies
Develop marketing messages and clinical story based on regional strategies, knowledge of current literature, current competitive environment, and regulatory/legal requirements
Lead major projects for the Congress Management process
Drive marketing collateral/labeling through all relevant legal and regulatory approval processes through collaboration with relevant cross-functional stakeholders for major product launches
Manage budgets related to product line, campaigns and projects
Analyze clinical and market data to assess regional impact of potential product launches
Build relationships with key opinion leaders (KOL) to help inform product launch plans and understand current market environment and competition

RA Manager

People Management経験不問です！

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

Company overview: We are an innovative solution provider specializing in the health and wellness sector in Japan. The company develops medical devices and healthcare solutions based on advanced technology and in-depth understanding. This helps improve the quality of healthcare and optimize patient care, thereby contributing to better health. The company also pursues sustainable innovation and contributes to improving health and wellbeing in society. We are committed to providing comprehensive healthcare solutions through a variety of partnerships and collaborations.
Responsibilities: 製造販売承認／認証申請、届出（計画立案、資料取集、PMDA／NB 照会対応）
承認／認証の維持管理業務（変更管理、定期更新）
QMS適合性調査申請
保険収載業務（保険適用希望書作成等）

Global Strategy Manager

グローバル戦略に携われるポジションです。

8.5 - 11 million yen Tokyo Medical Device Marketing

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: 職務内容
インナーブランディングとアウターブランディングの調和を図り、ブランドの好循環を生み出すための戦略、施策の企画を立案、実施する
コアバリューズを含む企業理念体系の継続的な社内浸透活動の施策を立案し、実施、推進する
ブランド規程やVIガイドラインに即したブランドコミュニケーションの実施やツールの作成・運用が行われるように、社内浸透活動、指導を行う
統一的なブランドイメージ醸成を図るため、コーポレートブランドデザインをグローバルに展開する

担う役割
広く社会から信頼され選ばれるブランドの確立を目指し、グループ全体のブランド価値を向上させるため、企業理念、パーパスおよび中長期成長戦略に基づき、全社的かつ長期的な観点から、社内向け、対外向けのコーポレートブランド戦略を立案し、施策を企画、実行する

Product Marketing (TAVI) | プロダクトマーケティング（TAVI）

製薬業界マーケティングからのご応募も可能です！

7 - 9 million yen Tokyo Medical Device Marketing

Company overview: Our primary business is the import and sale of medical devices, offering devices for testing and treatment of cardiovascular diseases. We have also entered the field of neurosurgery, which is a new business area for us. Our mission is to help healthcare professionals treating patients with cardiac, neurological, and chronic pain around the world gain access to superior treatment tools. We focuse on the development of medical technologies and services that contribute to the reduction of risk and the successful treatment of all patients.
Responsibilities: The TAVI Product Manager is responsible for setting strategic direction in Japan for the portfolio and for tactical implementation of activities aligned to a patient-centric, customer-centric and goal-achieving culture, leading to optimal clinical adoption, outcomes, and customer satisfaction within the space.The TAVI Product Manager is responsible for the following related to their portfolio:
Main responsibilities:
Develop Japan-specific marketing strategies and tactics for new product launches including market analysis, clinical strategy, reimbursement strategy, product positioning and messaging.
Contribute to the achievement of objectives via development and close execution of annual marketing plans.
Design and prepare the workflow, procedure, logistics and documentation required for product launch and business operation driving the cross-functional teams.
Plan and execute TAVI marketing tactics, especially for messaging for brand positioning and differentiation, peer to peer event to demonstrate product benefit, and activities to deepen customer engagement in TAVI market.
Set appropriate KPIs (leading KPIs, activity KPIs, clinical KPIs and performance KPIs) for marketing tactics, analyze data and track to take timely corrective actions as necessary
Leverage customer relationships, technical expertise and product knowledge to plan and coordinate new launches, and provide the sales team with appropriate messaging, campaigns and tools highlighting objective, relevant differentiation.
Develop promotional tools and optimize others provided by Global Marketing; launch with appropriate localization, training, and tracking.
Create open, productive lines of communication between the sales and clinical team and all other areas that affect the product: Regional and Global Marketing, RA, QA, etc.
Provide clinical and sales staff with clinical knowledge and promotional guidance, ensuring products are targeted appropriately to satisfy customer needs and expectations.
Stay up-to-date on key publications, trials, indications, society guidelines, and market dynamics and reflect to the communication / marketing strategy
Interface with Public Relations firms, market research companies; design agencies and other vendors and customers to effectively grow business in a profitable manner while maintaining a customer focus throughout all activities.
Develop and maintain professional relationships with key customer accounts as well as market influencers.
The TAVI Product Manager is responsible for achievement of the goals and objectives associated with their products including revenue, margin, and expense budget. Business Process goals will be measured against commitments in the annual marketing plan. Strict compliance with the company's Quality System and all Ethics/Compliance guidelines is required

Medical Education Manager

製薬の方歓迎

9 - 14 million yen Tokyo Medical Device Marketing

Company overview: Our client is a leading force in the global diagnostics industry, advancing healthcare through innovative diagnostic solutions. The Japan branch, based in Tokyo, employs approximately 500 professionals and supports a wide range of diagnostic products and services, including clinical chemistry, immunoassays, and molecular diagnostics.

Globally, the company operates in over 100 countries with more than 80,000 employees across various facilities and research and development centers. The firm\'s dedication to improving patient outcomes and advancing medical science drives its operations and ensures high-quality diagnostic solutions are available worldwide.
Responsibilities: 業務内容：
コミュニケーション戦略立案（マーケティング、営業、マーケットアクセスと連携し、正しい認知を加速する必要がある重要なターゲットセグメントを特定する。
ターゲットセグメントにおける市場調査などの実施を通じて、認知してほしい遺伝子検査の正しい理解や抗原検査との使い分けや違いについての認知ギャップを明確にする。
ターゲットとギャップが明らかになった後、予算内で効果的・効率的なコミュニケーション戦略と手法を立案し、ＧＭや関連部署の合意を取る。
必要に応じて追加予算を申請し、交渉し、獲得して進めていく。
戦略をもとに、効果的な戦術を立案し実行していく。特に、Webセミナー（TeamsやＷebex, Zoomなど）、疾患啓発冊子やWebサイトの製作、医師会や学会地方会のセミナーや、Public Affairsと連携したメディアプランなど。
PRエージェンシーやクリエイティブ制作会社と連携し、主要な企画を実行していく。

Senior specialist/manager, Regulatory Affairs

勤務地は東京or大阪（リモートワーク有）

7 - 9 million yen Tokyo Medical Device Regulatory Affairs (RA)

Company overview: Our Client is a global medtech company that provides medical devices, lab equipment, and diagnostic products in their focus areas such as medication management, infection prevention, diagnostics, and healthcare delivery solutions.
Responsibilities: Job Description Summary:
A global medtech company is looking for a highly motivated individual to join our team as Regulatory Affairs Specialist/Manager in the Pharmaceuticals Division. The successful candidate will be responsible for obtaining regulatory approval of new products and maintaining existing licenses in line with local regulations, while ensuring compliance with all relevant laws and regulations. This role will involve collaborating closely with cross-functional teams to ensure timely and effective product launches, as well as ongoing support for marketed products. The position requires excellent organizational skills, attention to detail, and strong communication abilities.
Job Responsibilities:
Lead and coordinate regulatory activities related to drug registration, including preparation of required documents and submission to authorities.
Collaborate with internal stakeholders such as R&D, Manufacturing, Quality Assurance, Marketing and Sales to gather information necessary for regulatory submissions.
Ensure compliance with all relevant regulations and guidelines, including GCP standards.
Stay updated on changes in regulatory requirements and guidance documents, and implement appropriate measures to address any impacts on current or future registrations.
Maintain accurate records of all regulatory documentation, including filings, correspondence, and inspection reports.
Support preparation and review of promotional materials to ensure compliance with regulatory requirements.
Coordinate interactions with regulators during site visits or meetings, providing clear and concise explanations of technical aspects related to product registration.
Work closely with external consultants and experts to facilitate smooth progress of registration process.
Provide regular updates to management regarding status of registration activities.

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