Jobs list of Medical Device
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Job number: JN -072024-169637 Posted: 2025-05-01
【Abiomed】Product Manager, Marketing
医療機器業界でのプロマネご経験者必見です！7 - 13 million yen Tokyo Medical Device Marketing
- Company overview
- We are a global medical devices and pharmaceutical company providing healthcare-related products. We offer a wide range of products including pharmaceuticals, medical devices, and consumer goods to support healthy living. Particularly, through investments in medical technology and research and development, we provide advanced medical solutions, enhancing the quality and efficiency of healthcare. Additionally, we contribute to raising awareness of health in society through education and outreach activities, aiming for a better future.
- Responsibilities
- Main responsibilities:
Launch and roll-out new products safely and successfully, and eventually, make the product the standard of care by working cross-functionally with the rest of Mktg, RA, QA, supply chain, field service, education, and the clinical sales team in Japan – as well as with the overseas headquarters including product & software engineering teams and downstream/upstream marketing teams.
Manage projects of product approval and reimbursement by working closely with RA, Medical Affairs, and the Reimbursement team.
Implement training plans with the Education team - including preparing user manuals, physician/staff/company employee training materials.
Develop and coordinate product supply and demand plans with SCM to ensure that product supply is delivered without delay.
Execute a marketing strategy with Marketing Director by building a deep understanding of the target market and the therapies where the product can be utilized. This includes products and software, and also by building strong relationship with Japanese KOLs.
Conduct marketing activities with Marketing Director through multiple promotional channels, including company-hosted events, academic societies, marketing materials, digital marketing, etc.
Collect feedback through internal stakeholders and physician/staff interviews, capturing both bright spots as well as aspects needed to improve a go-to-market strategy, value propositions, and key claims /messaging.
Provide professional clinical- and business-oriented support to clinical sales team as an Impella product/service expert.
Takahisa Hitotsumatsu
Medical Device -
Job number: JN -112024-179537 Posted: 2025-05-01
海外営業管理職 / 海外販売会社サポート業務（北米担当）
自分らしさが発揮できる会社6 - 11 million yen Tokyo Medical Device Sales
- 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
- 販売会社とのオンライン会議、海外出張ベースでの支援・遂行も含みます。本ポジションはアメリカを中心とした北米担当です。赴任の可能性を含みます。
業務内容：
主として、主力地域のひとつである米州の事業管理、地域改革プロジェクトの企画・実行
海外パートナー企業とのプロジェクトの企画・実行
担当地域向けDay-to-Day営業オペレーション・サポート業務
販売会社向けのサプライチェーンマネジメント業務
Takahisa Hitotsumatsu
Medical Device -
Job number: JN -112024-179545 Posted: 2025-05-01
Head of MSA
Work on impactful and meaningful work20 - 30 million yen Tokyo Medical Device Medical Affairs / Government Affairs
- Company overview
- Our client imports and sells allergy and autoimmune diagnostic solutions.
- Responsibilities
- Main responsibilities:
Lead and develop the Japan Medical and Scientific Affairs team to ensure strong alliances and consistency of medical and scientific strategies worldwide.
Conduct and manage clinical studies, from design through execution and analysis, aimed at supporting new product launches in partnership with marketing and QA&RA departments.
Establish medical and scientific evidence that proves the clinical advantages of our products.
Drive clinical needs for new product development in Japan and collaborate in related clinical studies.
Translate scientific data into actionable insights for customers and other departments based on proven professional expertise.
Establish and maintain solid relationships with internal teams and Key Opinion Leaders (KOLs) to improve the company's presence in the Japanese medical and scientific communities.
Gather insights from KOLs and field presence to inform the organization about trends and opportunities in allergy and autoimmunity.
Craft and deliver medical and scientific training to further develop organizational capability within Japan.
Manage and develop the MSA Japan team with integrity, emotional intelligence, and inclusion.
Stay updated on medical and scientific expertise across the product pipeline from development through commercialization.
Represent the division at national and international conferences, contributing to symposia and encouraging education and adoption efforts.
Offer clinical expertise and strategic mentorship for the development of medical and scientific strategy and business initiatives.
Support compliance and ensure product safety in all interactions.
Go Ozawa
Medical Device -
Job number: JN -072024-36443 Posted: 2025-05-01
Japan Marketing Director
癌領域の病理リーディングカンパニーでのマーケティングポジション10 - 14 million yen Tokyo Medical Device Marketing
- Company overview
- We import and sell microscopes and related equipment manufactured overseas in Japan. With a heritage dating back about 170 years, we represent a leading German precision equipment company, offering top-quality microscopes and peripherals imported and sold domestically. Through several corporate mergers since our inception, we emerged in 1990 as Leica Microsystems, a prominent European manufacturer of scientific instruments. Utilizing microscopes and associated equipment, we address the increasingly sophisticated observation, measurement, and analysis needs in the fields of life sciences and industry, providing optimal system solutions for users.
- Responsibilities
- Main responsibilities:
• Formulates and executes competitive marketing strategies and programs (campaigns, virtual events, trade shows, symposiums) achieving short and long- term revenue growth, ensuring that goals are consistent with the country’s growth initiatives• Collaborates internally to drive country activities, campaigns, product launches, content creation and Key opinion leaders’ management• Lead, nurture and develop the local marketing team• Lead all aspects of execution of promotional material including playbooks, social media, trade shows, direct mail, web content, digital marketing, informative binders, newsletters and industry news• Supervise event logistics & provide local event support, ensuring consistency with regional messaging. Manage the local part of translation processes and review of translated customer-facing materials for accuracy• Collect metrics to ensure marketing strategies, programs, and activities are executed effectively and delivering impact.
Takahisa Hitotsumatsu
Medical Device -
Job number: JN -082024-173320 Posted: 2025-05-01
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。
Shotaro Tsubaki
Medical Device -
Job number: JN -072024-39180 Posted: 2025-05-01
QMS Team Leader (Medical Device) | QMSチームリーダー（医療機器）
医療機器業界でのQMS管理経験が活かせます7 - 11 million yen Tokyo Medical Device Quality Assurance / Quality Control
- 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
- 品質本部QMS課のチームリーダーとして課員をリードしながら、当社におけるQMSの適切な維持管理及び運用をお任せします。※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：
ISO13485に基づいたQMSの維持管理及び、運用内部監査の計画立案、運営による、QMSの適合性維持、有効性の向上
文書管理、マネジメントレビュ、教育訓練、是正予防処置及び測定機器管理に関する実践
医療機器規制当局等（認証機関含む）による審査・査察への対応外部機関による実地監査対応の計画立案、運営、QMS適合性認証取得
外部機関による書面審査時の資料作成及び申請業務
法規制並びに国際規格に関する情報収集並びに各要求事項への適合性の確保
Takahisa Hitotsumatsu
Medical Device -
Job number: JN -072024-18366 Posted: 2025-05-01
Business Development Manager
【東京】大手外資系医療機器メーカーのBusiness Development10 - 14 million yen Tokyo Medical Device Business Development
- 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
- Coordinate teams of internal and external experts to evaluate product opportunities; the needs and merits of the company leadership and APAC/Global initiatives
Cross-functional due diligence teams include in-house and external including but not limited to manufacturing, regulatory, marketing, financial, legal, intellectual property experts
Manage the development of the business case and financial model with other internal functions/projects, and manage the overall assessment of interesting opportunities
Prepare and deliver presentations to the Japan and APAC/Global teams integrating and summarizing scientific, clinical, financial, and market information
Structure and negotiate terms of licensing agreements with potential business partners
Lead and support various Japan and regional initiatives including transformational projects and integrations
Expected Areas of Competence :
Able to direct regular review of markets and products to identify trends and opportunities
Foresees how decisions may impact the financial state of the rest of the organization
Understands how ideas are converted into successful development and commercialization and continuously works to improve these processes and impact profitability and growth share
Excellent interpersonal and presentation skills
Proven ability to communicate complex issues in a clear and succinct manner – both in writing and verbally
Strong financial acumen (P&L, balance sheet, cash flow, and budgets)
Go Ozawa
Medical Device -
Job number: JN -072024-30044 Posted: 2025-05-01
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
Shotaro Tsubaki
Medical Device -
Job number: JN -042025-187582 Posted: 2025-04-30
【茨城】粒子線がん治療装置の保守サポート（海外現地サイトの支援担当）
医療機器のフィールド業務経験者必見です!6.3 - 8.8 million yen Chiba Medical Device Service Engineer
- Company overview
- We provide tech solution products, inheriting numerous manufacturing equipment businesses and integrating trading and manufacturing functions to offer a wide range of products. Our business includes inheriting surface mount system business, LCD and hard disk-related manufacturing equipment business, and semiconductor post-process manufacturing equipment business, seamlessly integrating trading and manufacturing functions.
- Responsibilities
- 【職務概要】現地保守業務を行うチームのサポート業務を行います。
欧州、アジア、北米の海外サイトの定期保守、緊急対応など現地保守チームの業務が円滑に進むように、日本の窓口として、主として海外サイトの管理サポートを行います。
【職務詳細】装置引き渡し後の保守サポート業務。
保守計画の立案、実行、進捗管理、保守業務関係書類（見積、技術書類、手順書、仕様書など）の発行、予備品の見積発注書作成、輸出関係書類の作成。
ISO27000対応。
現地装置故障の場合には、休日・深夜のサポート業務、また緊急出張の可能性があります。
Shotaro Tsubaki
Medical Device -
Job number: JN -072024-151509 Posted: 2025-04-30
Inside Sales | インサイドセールス
AI医療製品・技術で世界を変える会社・副業可能5 - 7 million yen Tokyo Medical Device Sales
- Company overview
- Our client is a Japanese AI solutions company specializing in the healthcare sector. With expertise in medical data analysis and advanced AI algorithm development, they are dedicated to addressing key challenges in the healthcare field. Their solutions contribute to optimizing diagnostic support, treatment planning, and overall healthcare efficiency. Much of their investments go into the development of AI solutions for health-related applications, encompassing areas such as patient monitoring, predictive analytics, and overall health management/support.
- Responsibilities
- 現在開発中のAI医療製品（内視鏡AI医療ソフトウェア)のマーケティング活動の反響に対する適切なコミュニケーションの構築、および商談化させるまでを担っていただきます。新規製品のブランディング・マーケティング活動の一部を担い、反響の内容をマーケティングチームにフィードバックし、より良いプロモーション活動を実現することも大きな役割となります。
業務内容：
Web、SNS、イベント、セミナー、DM、紹介などを通して弊社製品（内視鏡AI）に興味を持って頂いた顧客に対するニーズのヒアリング
商談機会のアレンジ（訪問はアウトバウンドチームが行います）
マーケティングチームへのフィードバック、改善提案等
Go Ozawa
Medical Device -
Job number: JN -072024-19149 Posted: 2025-04-25
【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
Medical Device -
Job number: JN -072024-22566 Posted: 2025-04-25
薬事申請業務
日系大手医療機器メーカー 薬事申請業務6 - 9 million yen Tokyo Medical Device Regulatory Affairs (RA)
- 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
- 医療機器の薬事スペシャリスト画像診断装置の薬事申請診断支援装置(CAD)、診断用ワークステーション、内視鏡、X線診断装置、等 主にクラス２の医療機器
薬事戦略立案から、申請までの推進及び実施(承認申請、認証申請)米国FDA、欧州MDR対応等、世界展開する為の各国海外申請を含む
Go Ozawa
Medical Device -
Job number: JN -042025-187437 Posted: 2025-04-25
製品登録担当
医理工学系のバックグラウンドが活かせます。5 - 8.5 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- Our client is a global manufacturer specializing in optical technology and healthcare, offering a wide range of products and services. Our main business areas include precision optical instruments, medical devices, and consumer products. We possess advanced technical capabilities, particularly in eyewear lenses, contact lenses, and endoscopes, and we are dedicated to developing innovative products. Additionally, we utilize cutting-edge technology in fields such as semiconductor manufacturing equipment and optical components to enhance our competitiveness in the global market. Through advanced research and development and rigorous quality control, we meet customer needs and deliver high reliability and performance.
- Responsibilities
- 日本や海外における製品登録及び関連諸手続き
新製品開発において…他部署との連携を通じたタイムリーな製品登録
設計変更において…各国規制要求に照らした影響評価、変更申請の実施
Takahisa Hitotsumatsu
Medical Device -
Job number: JN -072024-149456 Posted: 2025-04-25
Regulatory Affairs Senior Specialist | 薬事シニアスペシャリスト
Class IV RAにご興味ある方が対象です7 - 9 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- We are a global medical devices and pharmaceutical company providing healthcare-related products. We offer a wide range of products including pharmaceuticals, medical devices, and consumer goods to support healthy living. Particularly, through investments in medical technology and research and development, we provide advanced medical solutions, enhancing the quality and efficiency of healthcare. Additionally, we contribute to raising awareness of health in society through education and outreach activities, aiming for a better future.
- Responsibilities
- 日本国内で心臓アブレーション治療や脳血管治療関連の製品を展開しています。その薬事担当としてクラスIV機器の新製品導入・適応拡大といったチャレンジングな薬事申請及び既存製品の維持活動を主たる業務とするポジションです。
業務内容：
海外製造元、ビジネス部門、臨床部門、品質管理部門等と協業
PMDA、MHLWとの交渉を成功に導くことで、承認取得から保険適用、製品発売、市販後の社内外のプロセスを完遂していただきます。
CSS RA Headにレポートします
Shotaro Tsubaki
Medical Device -
Job number: JN -072024-4978 Posted: 2025-04-25
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）
Shotaro Tsubaki
Medical Device -
Job number: JN -042025-187215 Posted: 2025-04-25
Lead Regulatory Affairs Specialist (Project Leader), Japan
Leading ｍedical device manufacture8 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- Our client stands as a prominent player in the field of medtech, providing a wide range of offerings including medical equipment, medical imaging processing devices, diagnostic tools, and life science-related equipment. It delivers products and solutions aimed at advancing diagnostics, treatments, and healthcare, operating across the comprehensive spectrum of medical technology and diagnostics.
- Responsibilities
- Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.
RA project leader is responsible for all RA tasks of own modality without detailed supervision by the direct manager. As a project leader, lead RA members to submit in time as necessary providing guidance from an experienced professional standpoint. Report to direct manager or to core-team co-workers about submission projects status when it’s requested. This role involves working closely with healthcare regulatory bodies and industry association and requires an in-depth understanding of key business drivers to accomplish work effectively.
Main responsibilities:
Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets.
Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory, product claims and country regulatory dependencies to ensure optimized sequencing for submissions.
Works with a cross functional team to prepare and submit regulatory submissions to regulatory authorities for the purpose of obtaining authorization for market launch.
Assesses changes in existing products to and determines the need for new /revise licenses or registrations.
Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.
Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
Contributes to writing and editing technical documents.
Assesses adverse events through approved license dossier to support Safety Management Team.
Understands and applies regulatory requirements and their impacts for submissions. (Monitor new/revised requirements and investigate the impact to Japan registration. Triage entry and to be Subject Matter Expert as required.
Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions (Access to multiple sources to get necessary information with clear objectives and strategies.)
Ensures compliance with pre- and post-market product approval requirements. (Lead communication with authorities as necessary and take appropriate action without detailed supervision of direct manager.)
Supports regulatory inspections as required. (Support direct manager to have internal and external audit.)
Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
Takahisa Hitotsumatsu
Medical Device -
Job number: JN -112024-179627 Posted: 2025-04-23
Senior Clinical Research Specialist
高クラス医療機器のClinical Study Manager7 - 10 million yen Tokyo Medical Device Clinical Trials / Clinical Development
- Company overview
- Our client is a world leading medical device manufacturer.
- Responsibilities
- ビジネス及び規制要件に則った臨床開発の戦略を構築しながら、治験及び市販後臨床研究（PMR）（以下、臨床試験）を実施するチームを管理運営する。またサプライヤー、政府関係者、病院関係者、医師などの外部関係者や海外の臨床試験チーム、社内の臨床試験チーム及び薬事部などの関連部署と協働して臨床試験を実施する。
業務内容：
試験担当責任者（CSM）の役割を担う
臨床試験の実施計画と実施計画書等の関連文書の作成。
PMDA及び/又は医師やその他のステークホルダーと臨床試験の進捗、方針等の実施に関する交渉を試験の立ち上げから終了後までの期間を通じた（結果の公表、承認申請準備含め）実施。
実施中及び新規の臨床試験に関する管理業務外部サプライヤーの選定
マイルストンの明確化と進捗の管理
施設及び/又は外部サプライヤーとの契約書の作成とその締結
EDCや紙の症例報告書を用いたデータ収集と社内システムを用いたデータ管理
マイルストン及びその予算計画の作成とその管理
治験機器の管理
必要に応じて解析計画の方針決定とその計画に沿った解析の実施やデータ公表に関する計画の立案と結果の公表
PMDA等に対する必要な報告及び対応
社内の監査チームに協働し、監査対応
外部の機関（PMDA信頼性保証課等）による適合性調査に対する対応
必要に応じて、直属の上長及びビジネス戦略上の事業部に対する報告、相談、対応
Go Ozawa
Medical Device -
Job number: JN -042025-187197 Posted: 2025-04-22
海外営業担当
PowerPoint、Excelピボットテーブルの知識、スキルをお持ちの方必見です5 - 8.5 million yen Kanagawa Medical Device Sales
- Company overview
- Our client is a leading medical equipment manufacturer in Japan.
- Responsibilities
- 日常業務：海外販社とのコミュニケーション、見積もり、商談対応が多いですが、その合間に、市場分析、販社教育、イベント企画、販促資料立案などの企画業務や、予算・見込・実績計数や輸出管理などの管理業務も遂行します。
地域性などにもよりますが、海外出張も年数回可能性があります。
Takahisa Hitotsumatsu
Medical Device -
Job number: JN -042025-187090 Posted: 2025-04-22
医療機器薬事リーダー
医療機器薬事申請において，薬事リーダーのご経験をお持ちの方必見です7 - 12 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
- Responsibilities
- 医療機器の薬事戦略立案から薬事承認までの推進及び実施（米国FDA対応等，グローバル展開を目的とした各国海外申請を含む）
同社品質保証部門との連携による各国法規制に準拠した医療機器の品質管理
Shotaro Tsubaki
Medical Device -
Job number: JN -092024-176696 Posted: 2025-04-22
アプリケーションスペシャリスト
技術営業経験（ライフサイエンス製品またはソリューション）をお持ちの方必見です。6 - 10 million yen Kanagawa Medical Device Service Engineer
- Company overview
- Our client is a leading global supplier in the fields of life sciences and clinical research from Europe.
- Responsibilities
- LSBの取扱い製品の管理、販売・技術支援を行います。
新人育成、プロジェクトなど必要に応じApplication Group Leaderの補佐を行います。
業務詳細：
本社からの製品技術情報フィードバック
営業部へのフィードバック及びアドバイス
顧客ニーズのフィードバック及び代理店支援
顧客への製品情報提供／技術説明
アプリケーション及びマーケティングの開発
商談案件の検討と評価
デモンストレーション
必要に応じてApplication Engineer Group Managerの補佐をする
製品販売支援
グローバルアプリケーション情報の収集
顧客満足度の向上
製品技術面に精通
営業会議に積極的に参加し、質の高い意見やフォローアップを提供する
商業部門の同僚やグローバルマーケティングチームと緊密に連携し、戦術やプログラムを開発する
チームセールス
品質マネジメントシステム（QMS）を理解し、遵守する責任を負う
Shotaro Tsubaki
Medical Device