Jobs list of Medical Device

Vet Channel (Account Manager)

長期的にコミットできる方がベストフィット

8.5 - 11 million yen Hokkaido Medical Device Sales

Company overview: Our client engages in the business of pet supplements, manufacturing, marketing and import/export of pet supplements.
Responsibilities: 犬猫用サプリメントの提案営業。取扱い製品の販売を最大化させるため、特約店、販売代理店を効果的にマネジメントすると共に、動物病院及びステークホルダーに対して直接の営業活動の展開をお任せ致します。 (フルリモート・ご自宅から直行直帰型の営業スタイル) 配属部署詳細営業チームは、獣医師、動物看護師、KOL を中心としたパートナーの成功を導き、サポートする組織として、当社では「パートナーサクセス」と呼ばれています。営業チームは、ユニークで高品質な製品を提供することで、獣医師からの推薦を強化し、ビジネスを推進する重要な役割を担っています。そのために営業チームは、事業目的、卸を含むステークホルダーの状況、私たちを取り巻く変化、チャネルの競争環境などを正しく理解し、アップデートする必要があります。
業務内容：
担当エリア各動物病院へ訪問し、推奨機会拡大のための営業活動を遂行
エリアマネジメントとエリア売上目標・KPI 達成
動物病院内での定期的なセミナー（エビデンスご紹介等）の実施・データ分析及び解析、担当エリアの課題・機会の明確化
販売店・パートナープログラム登録目標数管理
販売戦略・アクションプラン確定
販売実績トラッキング
営業管理ツール活用
営業経費適正使用
獣医師会・動物病院との関係を維持・向上
営業活動全般の PDCA による生産性向上
ミッション当ポジションは、ビジネスモデルを通し、ペット市場における製品ブランドの浸透を促進し、売上目標達成とともに事業部目標を遂行することが期待されます。
動物病院での院内セミナーを実施し、正しい知識をステークホルダーに伝え、犬猫の健康維持におけるサポートを行う。
製品を深く理解し、製品の価値認識を向上させ、プレミアムブランドとしてのポジションを確立することに貢献します。

キーアカウントマネジメント動物病院、特約店、担当代理店社用車貸与ご自宅から動物病院などへ直行直帰に使用していただきます。
お一人で活動することは多いですがチーム、部内での相談はいつでも可能な環境です担当エリア

Marketing Communications Lead

【東京】売り先の幅が広い医療機器のマーケティングコミュニケーション

6 - 9 million yen Tokyo Medical Device Marketing

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: 【具体的な業務内容】マーケティングコミュニケーション担当として、ビジネスのブランド価値を高め、中長期的な成長をドライブするための各種業務を行います。影響力のあるMarketing Toolsの作成やプロジェクトの推進、アピール力のある宣伝材料の作成を手がけます。
具体的な業務は以下の通りです。【業務内容】マーケティングコミュニケーション戦略の立案・実行
市場動向の調査・把握・分析
セミナー・展示会・イベントの企画・実行
KOL（Key Opinion Leader）マネジメント
社内ステークホルダーを巻き込んだプロジェクトの推進
営業担当者や販売代理店のセールス支援
グローバル本社や社内関係部署との協働・調整
Marketing tool の作成

Acute Care Marketing (Manager)

大手医療機器メーカーのマーケティングマネージャー

12 - 16 million yen Tokyo Medical Device Marketing

Company overview: We offer a wide range of medical equipment including orthopedic, neurosurgical, emergency medical, and operating room products. These include, among others, artificial joints, implants for bone fracture treatment, endoscopes, surgical instruments, and automated cardiac massage systems. Focusing on customer needs, the company strives to improve the quality of medical care through innovative products. We also continue to maintain a "rewarding work environment" by focusing on employee growth and improving the work environment.
Responsibilities: Main responsibilities:
Author and leverage marketing team to create key strategy documents: strategic plan, annual marketing plan, product launch plans, etc
Surface new or unexpressed customer needs, leading to product/program improvements
Adhere to organizational protocols, practices and procedures for gathering competitive information
Drive segmentation and targeting methods to improve commercial efficiency
Develop pricing approach consistent with the marketing strategy and brand positioning
Accurately forecast resource needs
Establish metrics and goals/success criteria and milestones
Demonstrate financial acumen
Hold self and others accountable to deliver high quality results with passion, energy, and drive to meet business priorities
Mentor, develop and inspire others
Collaborate and influence others on cross-functional teams, advancing partnerships to achieve business objectives
Develop key relationships with industry/market thought leaders, organizations, and institutions, in collaboration with other marketing leaders

医療機器開発 - プログラム医療機器の臨床開発

【東京】評価の高いプログラム医療機器の臨床開発

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

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: 【担当職務】AIを活用した医療機器の臨床評価設計や、医療機関・規制当局との連携を通じた承認取得業務などの多岐にわたる業務をリードしていただきます。＜具体的には＞①プログラム医療機器（SaMD）の臨床開発└性能評価試験の設計デザイン└試験計画書や承認申請書類等のメディカルライティング└試験の進捗管理及び施設対応や医師折衝└試験結果の統計解析・考察└CROコントロール及び管理└社内関連部門、外部審査機関との折衝②各提携先病院・大学との臨床開発や共同研究の推進└研究実施機関との契約及び倫理審査手続き└研究の進捗管理及び施設対応や医師折衝
【仕事の魅力】・最新の医療AI（SaMD）の開発に関わることができる・医療AIの社会実装を推進することで医療の質向上に貢献できる・多くの関係者を巻き込みながらプロジェクトを推進できる

Senior Specialist, Safety Vigilance

大手医療機器メーカーの安全管理

6 - 8 million yen Tokyo Medical Device Quality Assurance / Quality Control

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: Lead SpecialistもしくはSenior
Specialistにて募集しております。＜Lead Specialist＞
マネジャーの最小の指導の下、薬機法全般についての知識と経験を有し、円滑な安全管理業務の遂行を目的とする。複雑な案件にも対処する。当社が販売する製品に係る安全管理業務の適切な履行を職責とし、以下の事項を含む。・医薬品医療機器等法ならびにGVP省令を遵守した業務・安全管理情報に関わる受付処理から完了までの一連の業務（以下を含む）－行政当局への不具合報告ならびに渉外－苦情品の調査に係る外国製造業者との折衝、調査対象品の返送、調査報告書の作成－当社システムを利用した安全管理情報の処理及び管理－社内関連部門との協働（顧客対応に関する関連部門の調整役を担う）・社内関連部門との積極的なコミュニケーション（情報の共有と協力体制の確立）・その他渉外（行政対応、業界対応）
＜Senior Specialist＞
マネジャーの少ない指導の下、薬機法全般についての知識と経験を有し、円滑な品質保証業務の遂行を目的とする。当社が販売する製品に係る安全管理業務の適切な履行を職責とし、以下の事項を含む。・医薬品医療機器等法ならびにGVP省令を遵守した業務・安全管理情報に関わる受付処理から完了までの一連の業務（以下を含む）－行政当局への不具合報告ならびに渉外
－苦情品の調査に係る外国製造業者との折衝、調査対象品の返送、調査報告書の作成－当社システムを利用した安全管理情報の処理及び管理－社内関連部門との協働（顧客対応に関する関連部門の調整役を担う）・社内関連部門との積極的なコミュニケーション（情報の共有と協力体制の確立）・その他渉外（行政対応、業界対応）

海外マーケティング / 事業企画

日系大手医療機器メーカー

6 - 10 million yen Tokyo Medical Device Marketing

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: 「メディカルシステム」「コンシューマーヘルスケア」「イメージング」「産業機材」「ディスプレイ材料」「電子材料」
上記いずれかの事業部における海外マーケティング(1～3)／事業企画(4)／生産管理(5)
現法や現地代理店と連携して販売施策/販売計画の立案遂行管理
本社機能としての現法や現地代理店への経営指導、営業支援、業績管理
新規流通チャネル、顧客の開拓などの営業
事業課題の設定や事業計画の策定・推進など
生産管理(事業計画立案/遂行管理、需給管理)

Clinical Marketing TMTT

新規事業部のClinical Marketing

6 - 9 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: Lead business expansion, especially market share increase by penetrating compelling clinical contents with evolving related stakeholders
Main responsibilities:
Develop clinical contents strategy of congress seminar and BU initiated events with evolving stakeholders (Product marketing, Congress mgmt, ProfEd and Medical affairs) and review it periodically
Create compelling clinical contents for external dissemination
Proactively identify, assess, and summarize relevant clinical literature not only TMTT area but also related therapeutic area
Provide promotional training to sales team to implement and enhance clinical sales approach to deliver 'Values' to customers
Create meaningful contents (procedual techniques, case mgmt, competitor info etc) for internal use by attending congresses and communicating global team
Establish customer relation through creating clinical contents
Others

Regulatory Affairs Specialist

Global pioneer in healthcare industry

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

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: Main responsibilities:
Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation.
Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation.
Provide management team with regular updates on product registration and new regulations from government body.
Provides input on regulatory- related issues associated with compliance and achieving the business plans.
Prioritize and plan on product registration for his/her respective product lines.
Preparing, coordinating and submitting regulatory applications to the local health authority.
Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.
Provide the management team with regular updates on product registration.
Ensure product registrations are reviewed and renewed as required.
Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.
Lobby the local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
Supports tender operations by timely supply of accurate regulatory documents.
Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.
Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
Serves as regulatory consultant to marketing team and government regulatory agencies.
Complete the mandatory Quality training subject to the defined timeline.
And ensure compliance with internal Quality system and policy.

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.

CRD x Ambassador

営業リードの獲得にご興味ある方

7 - 10 million yen Osaka Medical Device Sales

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: Represents the business to targeted customers in order to increase awareness of the business and its brand, generate sales opportunities and build customer preference. Embodies what the company stands for and creates awareness, attention and sales lead opportunities.
Main responsibilities:
Represent the company and its products to the media and customers in a positive manner.
Has well-developed knowledge of the company’s sales and marketing goals and objectives and executes initiatives to achieve them.
Plan and implement awareness creating programs to reach out to potential customers.
Share customer feedback to the company in anticipation of improving products and services and participate in developing marketing ideas.
Develop and maintain strong communication with buying offices and customers.
Conduct product training and handle inventory preparation initiatives.
Monitor brand movement, pricing and distribution penetration.
Build and sustain business relationships with key accounts within assigned areas.

Product Manager PI_

Commit to both personal and professional commitments

10 - 14 million yen Tokyo Medical Device Marketing

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: Main responsibilities:
Drive top line by working closely with sales team while maintaining the business profitability and Gross Profit (GP) targets.
Develop and implement marketing strategies and tactics to maximize commercial outcome by working closely with internal functional teams: e.g. sales managers, trainers.
Work with/Establish KOLs via developing strong relationship in order to execute business unit strategy.
Work with sales trainers and build training programs for local sales teams and distributor reps to penetrate critical marketing messages, such as product positioning and competition analysis.
Build marketing plan for responsible products and obtain management approval as needed. See ahead to future possibilities and translate them into breakthrough strategies.
Obtain & update market insight by visiting current customers as well as prospects.
Prepare a new product launch plan and obtain management approval. Take an ownership for domestic product launch initiative.
Expand market through customer education and enlightenment of appropriate use.
Plan and execute events such as academic conferences, exhibitions, seminars and events for building and maintaining key customer relationship.

Lead Regulatory Affairs Specialist (Project Leader), Japan

Leading ｍedical device manufacture

8 - 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.

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

Marketing Communication

顧客Facingな仕事がしたい方歓迎です

8 - 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: Manage annual congress strategy and seek opportunities to expand company presence.
Main responsibilities:
Manage all national and regional medical congresses from development to implementation; provide support for global congresses as needed
Negotiate higher volume and complex contracts
Develop strategies for the effective management and execution of medical congresses, marketing events and projects intended to maximize company exposure and produce sales leads
Develop relationships with associations to ensure maximum exposure and greatest benefit for Edwards sponsorship and participation
Manage relationships with multiple vendors and lead vendor teams for congress execution and event management
Manage new booth development; audit booth asset inventory; remain current on new trends in exhibit design
Plan and execute educational symposia and customer events within medical congresses; contract negotiations, logistics, F&B, AV
Active budget forecasting, management and reconciliation; and fiscal responsibility
Lead cross functional teams to successful results

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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Product Manager (Marketing)

Improve lives through innovation & collaborative teamwork

6 - 9 million yen Tokyo Medical Device Marketing

Company overview: Our client is a foreign medical device manufacturer.
Responsibilities: Main responsibilities:
Product management and promotion work for medical devices and related solutions in the field of sleep apnea syndrome and respiratory related diseases.
Planning and executing product lifecycle management and marketing strategies for the product group in charge.
Education, clinical and product support for products and related treatments.
Domestic operation of in-house developed software.
Understanding and analyzing market trends.
Planning and implementing various academic conferences and events.

Regulatory Affairs Specialist | 薬事スペシャリスト

Inclusive and collaborative work place

5 - 7 million yen - Medical Device Regulatory Affairs (RA)

Company overview: Our client is a globally recognized leader in advanced medical technology, specializing in orthopedics, sports medicine, and wound management. With a strong presence in Japan, they have established a dedicated branch that plays a crucial role in delivering innovative healthcare solutions to the local market. Supported by a vast network of over 17,500 employees and multiple branches worldwide, including a significant footprint in Asia, our client remains committed to improving patient outcomes through cutting-edge products and services. Their expertise and dedication make them a trusted partner in the healthcare industry, both in Japan and globally.
Responsibilities: There are currently three staff members in the team. One staff member will be on maternity/childcare leave, so we would like you to take charge of the regulatory affairs during that time. In order to quickly obtain regulatory approvals related to new businesses, you will obtain information appropriately and apply early or submit notifications at the appropriate time. Obtain information and apply early and submit notifications at the appropriate time. In order to comply with pharmaceutical regulations, take appropriate action in accordance with the content agreed upon by the team.For tasks other than applications, you will play an active and central role as a project leader or core member.
Main responsibilities:
General duties (10%)Make and implement improvement proposals for business operations.
Provide support for various improvement proposals from other members.
Properly maintain and manage internal documents, etc.

Regulatory Affairs (90%)Plan and implement appropriate strategies for approval applications, approval, and insurance coverage for approved items.
Plan and implement strategies for applications, certification, and insurance coverage for certified items.
Prepare and submit manufacturing and sales notifications at the appropriate time.
Provide internal process support such as creating package inserts after approval/certification/notification until market launch.
Consider and implement change management for existing products and pharmaceutical change procedures for approval/certification/notification forms.
Review and edit advertisements and other external documents in accordance with pharmaceutical regulations.
Communicate with overseas manufacturers and related internal departments for pharmaceutical application work.

Senior Safety Control Specialist

Advance surgery, empower teams, and change lives

7.6416 - 11 million yen Tokyo Medical Device Regulatory Affairs (RA)

Company overview: Our client is the global technology leader in minimally invasive surgery.
Responsibilities: Main responsibilities:
Preparation and implementation of GVP in compliance with Japanese PAL.
Collection and first reviewer of local and overseas post-marketing safety information.
Review / approve the evaluation of local and overseas post-marketing safety information.
Manage an outsourced contractor daily work.
Complaint handling management for filings and prepare the customer letter.
Communication with head office on complaint cases for preparation of customer letter.
Support quality management activity and work with QA team to maintain the appropriate quality
management system.
Prepare and maintain the appropriate SOP for post-marketing filing, complaint handling and quality
management in a timely manner.
Continuous improvement and management of the safety/quality assurance process in accordance with Product Development Process.
Work directly with regulatory agencies on safety/quality issues and submissions.
Documentation of Package Insert and PMDA web maintenance of Package Insert

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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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.

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