Jobs list of Medical Device

Sales Representative

【横浜】測定機器等の技術営業

6 - 12 million yen Tokyo Medical Device Sales

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

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)

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

Senior Product Specialist – Japan ACM Marketing

製品の横幅の広い医療機器マーケティング

8 - 11 million yen Tokyo Medical Device Sales

Company overview: Our client is a world leading medical device manufacturer.
Responsibilities: 業務内容：
特定の製品または製品ポートフォリオの日本市場での成功に明確な責任を持つ事
担当製品の市場における営業戦略の立案・調整を行う。日本市場のダイナミズムを深く理解し、営業部およびグローバルビジネスユニットの担当者と緊密に連携し、効果的に戦略を実行する事
価格設定、品質関連事項の管理、および製品在庫管理といった、担当製品または製品ポートフォリオのライフサイクルマネジメントの責任を持つ事
既存・新製品の正しいバリュー・プロポジション(value proposition:価値の提案)を定義するために、市場調査を企画主導し、成長余地をとらえ、既存製品およびパイプラインにある製品のValue proposition(訴求価値)を定義し、戦略を策定する事

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

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Shotaro Tsubaki
Industrial & Life Science

Medical Affairs Manager

MA professionals from all therapeutic backgrounds welcome

9.6 - 12 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: The leading manufacturer of blood and peritoneal dialysis is seeking a candidate to engage and develop Key Opinion Leaders (KOLs) in scientific activities and establish the organization as a leader in science-driven healthcare.
The company is addressing a critical need in the dialysis treatment landscape, where 95% of patients currently rely on hemodialysis, which requires them to visit a healthcare facility three times a week. With peritoneal dialysis (PD) offering a groundbreaking home-based alternative, the company is uniquely positioned as the only provider of products for both treatment modalities, with a 70% market share in PD. As the prevalence of kidney disease continues to rise, this role offers the opportunity to make a significant contribution to expanding treatment options for dialysis patients.
They are looking for a talented individual to drive evidence generation and enhance the credibility of peritoneal dialysis in the marketplace, particularly as clinical results suggest it may be less harmful to the kidneys than hemodialysis. Medical Affairs Manager will play a critical role in gathering and synthesizing clinical data to expand treatment options and encourage hospitals that have traditionally focused on hemodialysis to adopt peritoneal dialysis. While prior experience in nephrology is not required, expertise in evidence generation is essential to effectively communicate new treatment options to physicians, ultimately benefiting patients and advancing healthcare solutions.
■Key responsibilities:
Developing clinical education initiatives in collaboration with national societies.
Providing medical content to marketing teams to ensure effective therapy related communication.
Educating healthcare professionals on the safe use of renal products and therapies for chronic peritoneal dialysis (PD) and hemodialysis (HD).
Support product launches and implement medical plans aligned with commercial strategies.
Serve as the primary scientific expert and support the therapy team in customer engagements.
Build relationships with KOLs to increase awareness and promote safe product use.
Collaborate on special projects within the therapeutic area, including medical affairs and CME.
Review promotional materials for compliance with regulatory and scientific standards.
Provide training and serve as a subject matter expert.
Drive the generation of clinical data to support therapies and maximize commercial opportunities based on customer insights.
The ideal candidate will drive innovation by integrating customer feedback into strategic planning while maintaining a strong understanding of the therapy landscape.

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MSL (Diabetes)

オンリーワンとも言える特徴あるプロダクトをもつ企業です

8 - 12 million yen Tokyo Medical Device Medical Affairs / Government Affairs

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: 【未来の糖尿病患者を救う革新的なソリューションを拡大するMSL募集／世界で100年以上続くグローバル医療メーカー】
低侵襲かつ持続的測定を可能とした自己血糖測定器で圧倒的なシェアを誇るグローバル医療メーカーで、メディカルサイエンスリエゾン（MSL）を募集しています。
長年の実績より専門医から厚い信頼を得ていますが、糖尿病患者が増え続ける中、早期診断を実現し、より多くの命を救うためには、専門医以外の認知度向上が不可欠であると考えています。
オンリーワンとも言える特徴あるプロダクトをもつ企業で、共に医療の発展を追求し、患者様の未来を救う機会がここにあります。
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FSE

仕事とプライベートのバランスを取りやすい

5 - 7.5 million yen Tokyo Medical Device Service Engineer

Company overview: We are a subsidiary to an international tech company known for its expertise in optics and optoelectronics. It has a strong presence in various industries, with products that appeal to both professionals and consumers alike.
Responsibilities: ■職務範囲：
顧客の光学顕微鏡の故障対応（現地・リモート）、現地及び社内修理作業、保守点検作業、セールスチームが受注したSystem系製品の現地納品及び動作確認作業、社内デモ機の出荷前点検及び現地デモセットアップ作業、修理案件で必要なスペアパーツの手配依頼を担当いただきます。また、アフターセールスとして、顧客の装置の状態を把握し、顧客との対話を通してニーズを潜在化し必要な提案を行う（アップグレード、オプション、ソフトウエア、保守契約、リモートサービス）活動も含まれます。
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製品の特長柄、休日や夜間のオンコールが少なく、仕事とプライベートのバランスを取りながら勤務いただけます。◎
顕微鏡の使用経験は問いません！グローバルグループのオンライン研修や、海外研修施設でのトレーニング、OJT等、独り立ちまでしっかりサポートがありますので、医療機器など、異業界からのキャリアチェンジも大歓迎です。
■業務内容：
LM機器のトラブルシューティング、修理作業、納品設置、保守点検（電話、メール、リモート、もしくは現場で不具合を解決し、機器のダウンタイムを最小限に抑える。担当エリア内の顧客に効率的にサービスを提供する。顧客の要望を理解し、適切な解決策を提供する。）
FSEでトラブルが解決しない場合、上位にエスカレーションさせて迅速な解決を即す。
社内の関係者（サービスチームリーダー、バックオフィス/カスタマーインターアクションセンター、アプリケーションエンジニア、営業等）と連携を取り、顧客の要望に応えるためサービス活動上必要な準備を整える。
トラブルシューティング用マニュアル（英語）の利用。
サービス事業の業績に関心を持ち、独立採算事業部門として予算化された数値目標達成に向けてチームの一員として活動する（タイムリーな修理作業終了後処理～パーツ引き落とし・請求依頼。新規保守契約加入提案、保守契約更新フォローアップ。顧客との対話を通して導き出されたニーズに対する提案によるアフターセールス品販売。
サービスオーダーや社内サービス記録をタイムリーにアップデート・管理する。
手持ちスペアパーツ在庫（カバン在庫）の状態に注意を払い、長期滞留、規定量オーバーにならないよう自主管理する。
グローバルで掲げるサービスエクセレンスを追求した活動指針を理解し、活動内容にネガティブなトレンドが確認された場合、上長に相談して原因究明し改善に努める。

■企業について：
170年以上続く歴史を持つ、光学技術のリーディングカンパニーです。長年の経験と革新的な技術によって、精密光学機器、顕微鏡、カメラレンズ、医療機器など、多岐にわたる製品を開発し、世界中の様々な分野で活用されています。業界における圧倒的な存在感：
世界でトップクラスのシェアを誇り、その技術力は業界において広く認められています。特に、顕微鏡分野での存在感が大きく、研究開発や医療現場において重要な役割を果たしています。またカメラレンズにおいても、多くのカメラメーカーから信頼を得ており、世界初の月面着陸の記録にも使用されています。
堅実な財務基盤と成長戦略
：長年にわたり安定した収益を上げており、また常に将来を見据え、研究開発に積極的に投資しています。
グローバルにおける位置づけ
：世界でもAPACの売上比率が年々増加しており、日本は同社における成長戦略の一部と位置付けられています。

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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

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Regulatory Affairs

The world leading company of Medical Device

6 - 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: 【世界最大級の医療メーカーにて、不整脈や脳血管治療関連の製品を製造販売する事業グループで、薬事担当者を募集しています】
■主な業務・役割：
新製品や新機能に関する製造販売承認の取得。申請・届出資料の作成や規制当局との照会回答の対応に加え、担当する製品等の薬事承認の迅速化、または価値の最大化を狙った申請等の戦略の立案、実行も含まれます。
クラスＩ、III、IVの医療機器の薬事ライフサイクルマネジメント（規制や製品に起こる変更への薬事的影響の評価と必要な薬事アクションの実行）
広告審査
保険適用希望書の作成、提出（A1、A2、B1、B2申請）
他部門との協働
その他業務（部門・組織の改善またはイベント実行に係る活動への参画を含む)）

■ポジションの魅力：
年間売上の約12％を研究開発に投資する同社だからこそ、新製品上市に関わる薬事申請の経験を継続的に積むことが出来ます。
ClassⅣの製品に関われますので、薬事として更なるステップアップが実現できる環境が整っています。
ご入社当初は、不整脈や脳血管治療関連の製品をご担当いただきますが、ご希望に応じて他製品（手術関連製品やアイケア領域など）への担当変更も可能となります。
社員のワークライフバランスを重要視しており、週2日のリモートワークやフレックスタイム制を利用可能です。

■企業について：
同社グループは消費者向け製品、医療機器、製薬といった多様な製品ラインを持っており、経済の変動や市場の変化に対して強い耐性を持ち、持続的な成長を実現しています。また、イノベーションを企業の核と位置づけ、毎年多額の研究開発費を投じています。新薬や医療機器の開発において、科学技術の最前線での進展を追求しており、これにより市場競争力を維持し、長年医療の向上にも貢献してきました。また、社員の創造性や革新を重視する文化が根付いており、新しいアイデアや改善提案が評価される風土があります。イノベーション推進やチームワークを重視した働き方が奨励されており、主体性を持って働くことができるため、社員へ自己実現の機会が多く提供されています。社内異動制度もあり、自身の専門性を高めながら多様な経験を積むことができるため、キャリアの成長を促進する環境が整っています。
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Takahisa Hitotsumatsu
Industrial & Life Science

Quality Management Specialist/ Sr.Specialist

医療機器の品質管理や製造販売後安全管理のご経験が活かせるポジションです

6 - 9.5 million yen Tokyo Medical Device Quality Assurance / Quality Control

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: 世界トップクラスのトータルヘルスケアカンパニーで、製造販売後の品質保証、QMSの構築・維持をお任せできる方を募集しております。不整脈治療領域における高度な技術力と幅広い製品ラインナップを強みとし、長年に渡り国際的な競争力を維持しています。社員一人ひとりの成長を支援するキャリア制度や、ワークライフバランスに配慮した福利厚生制度が充実しており、外資系でありながら高い定着性も魅力です。
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主な業務内容：
◆品質マネジメントシステム構築・維持・改善関連業務 QMS 省令及び同社Quality Policy に準拠した品質マネジメントシステム文書の制定及び改訂の実施
他部門による品質マネジメントシステム文書の制定及び改訂のサポート
国内関連法令や通知等にかかる情報入手及び影響評価の実施
同社Quality Policy 及びその下位文書の制改訂のモニター及び影響評価の実施
◆品質問題対応業務データ分析の実施による品質問題の検出
関係者（製造元、安全管理部門、各事業部）との協同による早期問題解決
顧客や行政、社内関係者への説明・対応

#poweredjob1

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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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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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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戦略推進チーム　プログラムマネージャー

業界不問/日本を代表する医療機器メーカーでのグローバルレベルのPMOポジション

8 - 11 million yen Tokyo Medical Device Training / Education

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: 同社は5万点以上の製品を160以上の国と地域に展開している総合医療機器メーカーです。2023年度は過去最高の売上収益・営業利益・当期利益額を更新し、売上高1兆円規模も目前に迫っています。
同社の戦略推進チームの一員として、グローバルプログラムの運営管理を主導していただける方を募集します。今回は、医療業界のバックグラウンドをお持ちでない方にも門戸が開かれています。部門横断のプロジェクトマネジメントスキルと英語力を活かし、医療の現場にある課題と向き合いながら、新たな価値創出に取り組む一翼となりませんか？
【募集背景】心臓血管事業において、事業最適化と事業間のシナジー創出を目指す大規模なグローバルプログラムを立ち上げました。このプログラムを主導的に運営できる人財を広く募集しています。

【職務内容】心臓血管事業全体でのシナジー創出を目的としたプログラムの企画・推進を担当していただきます。具体的には、以下の業務を主にお任せします。プログラム全体方針策定
事業間コラボレーション案件の特定、実施可否判断支援
各種プロジェクトの立ち上げと進捗管理、クロージング（PMO）など

【仕事の魅力】同社最大規模の事業部における重要なプロジェクトを、各事業の責任者と共に進めることができます。全社視点での成長戦略の実現に貢献できるだけでなく、様々なビジネス領域や国内外のプロジェクトの進捗管理に関わることができます。
経営層との距離が近いため、直接影響力を持つことが可能です。

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内視鏡開発のプロダクトマネージャー（Regulatory Affairs）

挑戦できる文化あり／課題解決に役立てる環境

5 - 8 million yen Tokyo Medical Device Regulatory Affairs (RA)

Company overview: We specialize in the development, manufacturing, and distribution of medical and scientific equipment. We are particularly renowned for our expertise in fields such as endoscopy and digital camera technology. We prioritize quality and innovation in our products, playing a crucial role in the medical and research sectors. Furthermore, we tailor solutions to meet the needs of our customers, providing support to medical and research institutions worldwide.
Responsibilities: 本部署では、新製品開発における製品登録および既存製品に関する規制対応Regulatory Affairsの視点から担当します。グローバルコミュニケーションが必要で、R&D、QA、工場との連携しながら業務を遂行いただきます。
業務内容：
製品開発の初期段階から、Regulatory Affairsの視点で申請書類を作成サポート
海外での製品登録およびその他の地域での登録サポート
既存製品の市場維持のためのRegulatory Affairsサポート
海外拠点とのコミュニケーション

Service Commercial Director

自分の仕事が世界にもたらす変化を実感できるグローバルな会社

13 - 19 million yen - Medical Device Marketing

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: Main responsibilities:
Responsible to develop and execute the Go To Market approach for assigned portfolio of products, solutions, services in alignment with the Markets’ Business and overall Marketing strategy
Works with the Business to ensure perfect and flawless New Product Introductions and Launches.
Supports the Business Marketing & Sales Leader (BM&S) in the interactions with the Business, especially the BMC process.
Supports and coaches the Modality Sales and Clinical teams in the Market as a one point contact to the Business and ensures Marketing strategy and plans are aligned.
Portfolio of products, solutions and services is large and complex

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。

Medical Affairs Manager

腎症に詳しい元医療従事者の方必見です

10 - 13 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: Establish medical affairs as strategic partner to business by developing therapy area strategic goals and execution plans in active partnership with local, regional and global marketing and medical to support yearly and long term plans for business strategy and goals To ensure compliance for all medical affairs related activities with ethics and integrity Building & enhancing the scientific image of the company (internal & external)
Main responsibilities:
KOL and professional society ManagementDevelop, nurture and engage KOLs and professional scientific societies in scientific exchange activities that differentiate the company as a scientifically driven healthcare organization. Represent the company medical affairs to external stake holders.

Medical Affairs Strategy & Implementation Develop 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 in close collaboration with various stakeholders towards conduct of clinical studies to generate scientific data supporting the company's therapy areas of interest
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

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.

Solution R&D

国内外の表彰多数／実行力強化研修あり

10 - 12 million yen Tokyo Medical Device Product Engineering

Company overview: We specialize in the development, manufacturing, and distribution of medical and scientific equipment. We are particularly renowned for our expertise in fields such as endoscopy and digital camera technology. We prioritize quality and innovation in our products, playing a crucial role in the medical and research sectors. Furthermore, we tailor solutions to meet the needs of our customers, providing support to medical and research institutions worldwide.
Responsibilities: 本組織では、地域ごと・製品ごとに部分最適となってしまっている医療機器のソフトウェア開発を、グローバルレベルでソフトウェア技術の方針策定や技術的な指導を担う組織となります。その中でも今回の採用ポジションのミッションは、Software Defined Medical Deviceのビジョンを実現するために、クラウドベースのビデオプロセッサの戦略のコンセプト定義やビジネスモデル提案の推進を行うことです。
業務内容：
将来製品のコンセプト定義推進リード。（提供価値定義、ビジネスモデル(収益/コスト)設計、コンセプト設計など）
プロジェクトマネージャーやマーケティングなどのステークホルダーと連携して、１で定義したコンセプトを検証する
コンセプトデザイナーとして、重要なコンセプトに関する決定の主導。
コンセプトデザイナーとして、コンセプト/ビジネスに関わる問題 / 課題 / リスク管理とその対応。
コンセプトデザイナーとして、ステークホルダーへの成果物説明。
新しいコンセプト/テクノロジーのビジネスプランとマーケティングシナリオを作成し、事業側のマーケティングチームとビジネス目標や目的と一致させる。
チームビルディング及びマネジメント協力的で革新的な職場環境の構築。
チームメンバーに対するトレーニングや開発の機会の提供

変更の範囲会社の定める業務
入社後のキャリア入社後、まずは本ポジションにおいて重要な将来製品戦略(エッジデバイスのクラウド化など)のテーマのコンセプト策定をマネジメントしていただきます。
その後は、グローバルレベルで既存のクラウド戦略やクラウド事業をミックスしながら仕事の幅を広げることができます。
技術開発だけではなく事業側との連携が必要となるため、技術と事業の両軸での知見を蓄えながらキャリアを形成することができます。
医療機器という、長期的に成長が見込まれている分野で、ユーザ価値・ビジネスコンセプト創出ができ、グローバルでの活躍も可能です。

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

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