Jobs list of Medical Device
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Job number: JN -072024-30333 Posted: 2024-09-11
Senior Medical Affairs Manager
Unique expanding market in Japan12 - 14 million yen Tokyo Medical Device Medical Affairs / Government Affairs
- Company overview
- We are an international healthcare company engaged in the development, manufacturing, and sales of medical products. We believe that everyone should have the opportunity to live a healthy life free from disease and full of possibilities. To achieve this vision, we dedicate ourselves fully each day to promoting innovation and providing smarter, more personalized healthcare solutions. We partner with healthcare professionals in hospital settings such as patient rooms, operating rooms, and intensive care units, as well as in dialysis facilities and patients\' homes. Our goal is to enhance treatment efficiency, improve access to care, prevent complications, and ultimately improve patient outcomes. We strive to deliver a range of better products that also consider healthcare economics, ensuring that we contribute positively to both medical treatment and economic aspects.
- Responsibilities
- Main responsibilities：
Patient Advocacy & engagement for Home dialysis:
Develop relationships & drive patient advocacy for Home dialysis with key patient organization to ensure productive partnerships that build on shared patient-focused objectives
Create and execute collaboration plans with key patient groups & HCP societies based on areas of mutual interest, identify opportunities to educate and empower patient and caregivers and build innovative solutions that address relevant public health, economic and clinical issues
Lead and assist in the development of patient advocacy focused medical/scientific information resources for various media platforms and properties and monitor metrics.
Represent patient advocacy and patient perspective in relevant cross functional meetings to elevate the perspective of people living with kidney diseases and their families and advocacy organizations.
Medical Affairs Strategy & Implementation: Input to Medical affairs strategy related to pre-launch, launch and post launch activities: conceptualize and implement Medical plan in unison with commercial strategy) to support improving patient outcomes
Establish evidence generation plan( Investigator Initiated studies) in close collaboration with various stakeholders towards conduct of clinical studies to generate scientific data supporting the company's therapy areas of interest
Support clinical trials for new product development through key scientific inputs & HCP engagement
Develop High Impact Clinical education( non-promotional education) and voice of customer( advisory boards) initiatives in close collaboration with National societies
Work closely in a cross-functional approach with the therapy unit to identify the unmet needs and bring voice of customer to the table cultivating innovation – medical advisory boards
Develop Digital education initiatives: webinars, digital education contents on therapy
KOL and professional society Management
Cross functional insights & support:
With marketing team: Design/provide medical insights for the Marketing team and strategize dissemination of therapy-related communication to support brand management
With regional teams: Effectively interface with the regional and global team to ensure optimal implementation of regional & global initiatives.
With Market access teams: Effectively interface with market access to provide subject matter expertise that enables resolution of market access and funding issues. This includes working closely with the Market Access team in designing and implementing the HEOR studies/data.
With commercial excellence: Therapy training to commercial team
With business development team: provides insights towards medical due diligence activities
Compliance: Review of promotional material & material for submission to regulatory authorities
Provide therapy training to the commercial colleagues.
Linh Do
Medical Device -
Job number: JN -072024-31537 Posted: 2024-09-11
医薬品エキスパート（コンビネーション製品）
大手医療機器メーカーでの品質保証案件6 - 10 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- We are a leading Japanese manufacturer and distributor of medical devices and related products. We have a particularly strong reputation in the field of medical devices, such as catheters and artificial heart-lung machines, and we are expanding our business widely both domestically and internationally. We are also expanding into the fields of pharmaceuticals and blood systems, providing comprehensive medical solutions. We focus on innovation and quality control, and develop our products with patient safety and healthcare professionals\' convenience in mind. We aim to contribute to the development of healthcare from a global perspective and are actively involved in the realization of a sustainable society.
- Responsibilities
- 当社ではファーマシューティカルソリューション事業へ注力しており、これに伴い医薬品（コンビネーション製品）の品質保証体制強化が必要となっている。原薬管理などの上流から、製剤製造まで監査、指導ができ、且つグローバルで活躍できる人財が求められている。
業務内容：
薬事省令対応（GQP、GMP、QMS）
FDA査察対応
GMP適合性調査申請
原薬／医薬品製造所のGMP／QMS適合状況、品質保証体制確認、指導のための実地監査の実施
国内外上市医薬品製品等の初期流動品質の確認・監査
医薬品類（特にコンビネーションデバイス）の品質保証体制の強化・牽引
Takahisa Hitotsumatsu
Medical Device -
Job number: JN -072024-31538 Posted: 2024-09-11
品質マネジメント担当者
Japanese multinational IVD manufacturer7 - 10 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- We are engaged in the medical field, specializing in clinical diagnostics. As a leading company in the industry, we provide valuable technologies and biomarker products. Our mission is to create new value in the healthcare market and contribute to the future of health and medicine. Since successfully commercializing products such as the syphilis test kit "Syphilis HA Antigen (TPHA)," we have been involved in research, development, manufacturing, and marketing, bringing innovation to the global clinical diagnostics industry. Particularly as a leading company in the field of immune sera, we have significantly contributed to medical advancement through the development of highly sensitive automated immunoassay instruments and dedicated reagents, as well as the development of rapid immunodiagnostic kits. We have garnered worldwide attention by swiftly succeeding in the development of a rapid antigen test kit for the novel coronavirus (SARS-CoV-2), demonstrating our commitment to providing highly socially impactful and necessary products.
- Responsibilities
- 本ポジション（品質保証部品質マネジメント課）は、当社全社の品質マネジメントシステム（QMS）の構築、維持、管理、改善を担っており、当局の査察にも対応するなど当社ビジネスの安定な運営に不可欠な部署です。既存事業などの体外診断用医薬品を販売するにあたり、法規で求められている品質マネジメントシステムの管理を行っている組織です。加えて当社の新規事業であるCDMO（受託開発製造）事業の拡大に伴い、B to Bにも十分対応できる当社の品質システムへのブラッシュアップが必要であることから、現状のQMSを維持しつつ、QMSの変革についてイニシアティブを率先して取り組む人員を募集いたします。将来的には品質マネジメントシステムの全社責任者への登用が期待されます。
業務内容：
以下の業務執行にあたり、企画立案、課題解決、PJ推進、要員管理などのマネジメント業務に当たります。
品質マネジメントシステムに関する文書改訂、ＣＡＰＡとりまとめ、データ解析、改善提案、査察対応"
他部署（ＯＰ本部、Ｒ＆Ｄ本部など）の新規業務や改善に対する妥当性確認、検証、改善
当ホールディングス各社及び外部CDMO関連会社との委託業務の管理や連携業務
Takahisa Hitotsumatsu
Medical Device -
Job number: JN -072024-39269 Posted: 2024-09-11
MRI・X 線診断装置のサービスエンジニア
サービスエンジニアのご経験がある方必見です。5.5 - 8.5 million yen Tokyo Medical Device Service Engineer
- Company overview
- We are a leading global company that materializes and provides cutting-edge science as products and services. We specialize in the field of science business, where we observe matter at the scale of molecules and atoms. We bring together core technologies in areas such as low temperature, high magnetic fields, ultra-high vacuum environments, nuclear magnetic resonance, X-ray, and electron/optical measurements.
- Responsibilities
- 医療用画像診断装置（MRI、X線診断装置）のサービスエンジニアとして全国の病院に設置された医療用機器の据付設置作業、定期的な保守、及び故障が発生した際の修理業務を行います。
国内外の医療機器メーカーのサービスパートナーとしてサービスを提供するため、直接のエンドユーザーとの折衝が基本発生しません。
1年程度のOJT期間及び海外研修を修了した後、各現場へ単独訪問し上記業務を行っていただきます。
本ポジションでは英語力を活かしてイギリスを中心とした海外でのサービスエンジニアとしての活躍を期待しております。
Risa Harada
Medical Device -
Job number: JN -082024-173536 Posted: 2024-09-11
医療機器の品質保証(管理職候補)
内部監査、外部監査経験がある方必見です。5.5 - 8.5 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- -
- Responsibilities
- ISO13485、QMS省令の体制構築
QMS・各省令に対応した社内規定の運用と維持
市場への出荷可否判定
不適合品の対応（外国製造所対応、状況確認、分析、解析、評価、是正・改善）
各手順書・標準書の制定、改訂
受入検査工程、出荷検査工程の管理業務
将来的に、国内品質業務運営責任者としてご活躍いただく予定となっております
Risa Harada
Medical Device -
Job number: JN -082024-171310 Posted: 2024-09-11
QAマネージャー
医療機器業界での品質保証もしくは薬事経験（目安3年以上）をお持ちの方必見です。8 - 12 million yen Tokyo Medical Device Quality Assurance / Quality Control
- 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
- 新製品導入や製品設計、製造プロセスなどのGo/No-Goの最終承認
品質関連文書の発効承認（他組織との品質契約書、品質関連の自社規定諸・手順書、資材規格書、製品規格書、製品標準書など）
製品やシステムに関する新規PJTに対する品質観点からのガイド（国内外他社との交渉を含む）
顧客クレームのプロセス管理（KPI管理）、個別クレームに関する対応・措置検討決定、個別顧客への対応（顧客訪問など）
製品の出荷停止、製品回収、その他の市場措置対応の決定に関する関連部門との調整および措置決定・措置実施完了までのリード
所轄省官庁、第三者認証機関との調整と対応決定・対応実施完了までの管理
各署との交渉や調整
Takahisa Hitotsumatsu
Medical Device -
Job number: JN -082024-170838 Posted: 2024-09-11
【東京】医療用内視鏡の安全管理（スペシャリスト）
医療機器業界における安全管理業務経験者必見です!8 - 12 million yen Tokyo Medical Device Quality Assurance / Quality Control
- 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
- 苦情に関する、不具合報告要否判断
不具合報告書作成およびレビュー
回収（改修）要否判断
回収（改修）報告書作成およびレビュー
行政とのやり取りおよび必要な対応の実施
研究報告書作成およびレビュー
外国行政動向調査実施
外国措置報告書作成およびレビュー
PSUR（安全性定期報告書）作成およびレビュー
市販後業務に関する社内手順書作成およびレビュー
添付文書改訂
文献調査
【変更の範囲：会社の定める業務】
Takahisa Hitotsumatsu
Medical Device -
Job number: JN -072024-33814 Posted: 2024-09-11
Sales Operations Analyst III (Commercial Enablement)
【東京】コマーシャルオペレーション x 大手ライフサイエンス企業6 - 8 million yen Tokyo Medical Device Commercial Excellence / Sales Operations / SFE
- 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
- 事業部の実施したいことのサポート・業務効率化に関する課題抽出・解決策提案・実行
課題が明確ではない場合でも、コミュニケーションを通して真の課題を引き出すこと
課題を解決するためのプロセス・システムを検討し、解決すること
商談管理・活動報告などのデータ活用推進業務
ユーザ管理など管理者としての業務
各種レポート・ダッシュボードの構築、および関連するデータの整備
Go Ozawa
Medical Device -
Job number: JN -072024-33815 Posted: 2024-09-11
District Manager, Account Management
生命科学の研究動向に関心があり、顧客との関係構築をリードできる方必見です。10 - 13 million yen Tokyo Medical Device Sales
- 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
- 国内のセールスチームをリードしていただきます。マネージャーではありますが、キーアカウントの攻略にrepと共に実行、研究者との強い関係構築を行って、BID製品の市場拡大をエンドユーザーに働きかけてメーカー主導で力強く実行していくことが求められます。よって、幅広いBID製品をチームメンバーとともに習得し、新しい情報や提案内容をタイムリーに顧客提案していくことをチームとして実行していただくことになります。
担当製品は各ブランドを代表とする分子生物学、細胞培養、細胞解析用の研究用試薬類、プラスチック消耗品や小型卓上研究機器です。契約販売店を通しての販売様式をとっているため、代理店の活用も顧客開拓と共に実行していきます。
Go Ozawa
Medical Device -
Job number: JN -072024-32472 Posted: 2024-09-11
製品開発部長
再生医療の製品開発部長 ・立ち上げフェーズ・医療機器10 - 13 million yen Tokyo Medical Device Product Engineering
- Company overview
- Our client is selling, importing and exporting pharmaceuticals and other products.
- Responsibilities
- 業務内容：
バイオマテリアル製品（医療機器）および手術用機器・デバイスの開発
製造工程開発および製造委託先の管理
QMSにおける設計管理工程のマネジメント
組織構成：マネージャー（課長）２名、他部員１３名
Go Ozawa
Medical Device -
Job number: JN -072024-32955 Posted: 2024-09-11
クリニカルスペシャリスト
臨床検査技師として、心臓超音波検査経験が活かせます。5 - 8.5 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
- 新規治療デバイスに関し、医師およびコメディカルに対し製品の取扱い説明
適正使用のための説明会・トレーニング等の運営
社内関係部署に対してのトレーニング実施
トレーニング資料・学会レポート作成
Shotaro Tsubaki
Medical Device -
Job number: JN -072024-25910 Posted: 2024-09-11
Clinical Consultant
循環器領域のクリニカルスペシャリスト6 - 9 million yen Tokyo Medical Device Clinical Specialist
- 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：
症例を通じた製品の安全使用臨床位置の確立
製品の使用を最大化するために、高い製品知識、臨床知識を保持し、正確な製品知識と添付文書の理解をしたうえで、HCPのニーズ、レベルに応じた質の高いコミュニケーションの実施
症例成功のためのHCPへのコンサルテーション
症例獲得のための継続的な情報収集、必要な関係者へのタイムリーな情報共有
製品の適正使用を最大化するための定期的な病院訪問とHCPとの関係構築
あらゆるHCP病院関係者に対する製品の情報提供
社内外教育に関わる資料の作成
営業社員への情報提供や社内トレーニングの実施
Go Ozawa
Medical Device -
Job number: JN -072024-39279 Posted: 2024-09-11
サービスエンジニア
サービスエンジニアのご経験 をお持ちの方必見です。5 - 8.5 million yen Tokyo Medical Device Service Engineer
- Company overview
- We are a leading global company that materializes and provides cutting-edge science as products and services. We specialize in the field of science business, where we observe matter at the scale of molecules and atoms. We bring together core technologies in areas such as low temperature, high magnetic fields, ultra-high vacuum environments, nuclear magnetic resonance, X-ray, and electron/optical measurements.
- Responsibilities
- 医療用画像診断装置（MRI、X線診断装置）のサービスエンジニアとして全国の病院に設置された医療用機器の据付設置作業、定期的な保守、及び故障が発生した際の修理業務を行います。
国内外の医療機器メーカーのサービスパートナーとしてサービスを提供するため、直接のエンドユーザーとの折衝が基本発生しません。
1年程度のOJT期間及び海外研修を修了した後、各現場へ単独訪問し上記業務を行っていただきます。
本ポジションでは英語力を活かして海外でのサービスエンジニアとしての活躍を期待しております。
Risa Harada
Medical Device