Jobs list of Medical Device
-
Job number: JN -062025-189434 Posted: 2025-06-20
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
Go Ozawa
Industrial & Life Science -
Job number: JN -062025-190072 Posted: 2025-06-20
【大田区】法規・規格対応(ソフトウェア関連)
国際規格の策定の経験者必見です!5.3 - 10 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- Our client is a leading medical equipment manufacturer in Japan.
- Responsibilities
- 当社製品のソフトウェア関連の法規・規格への対応を、製品共通として推進します。
医療機器ソフトウェア関連の法規・規格（サイバーセキュリティ、SaMD（Software as a Medical Device）、AI等含む）に関する情報収集／分析
社内ガイドラインの策定、プロセス策定
工業界を通じて、医療機器ソフトウェア関連の法規・規格の策定に参画（意見の提出等）
製品共通のサイバーセキュリティ対応の実施（製品向けGPO（Group Policy Object）の作成、等）
Takahisa Hitotsumatsu
Industrial & Life Science -
Job number: JN -062025-189702 Posted: 2025-06-19
【名古屋】海外営業
貿易実務全般経験者必見です!5 - 8 million yen Aichi Medical Device Sales
- Company overview
- -
- Responsibilities
- 業務用美容機器メーカーの当社にて、国内での営業活動に加えて海外対応も行う営業職を募集します。
国内での営業活動を中心に、海外展示会対応・英語を活かした受注業務もお任せします。
業務詳細:
国内のエステサロン・美容関連企業への営業活動（主に既存） 電話やHPでお問い合わせを頂いたお問合せに対して、自社商品の営業を行う「反響営業」となります。反響営業の為、飛び込みはなくお客様に向き合った営業をすることができます。
海外展示会への参加（社長同行・通訳・商談対応）
海外顧客からの受注対応
貿易実務業務（インボイス作成、出荷管理など）
Go Ozawa
Industrial & Life Science -
Job number: JN -042025-186211 Posted: 2025-06-19
【東京】QcRM/RAシニアスペシャリスト◇フルフレックス◇グローバル医療機器メーカー
フルフレックス／年休125日以上／グローバルで活躍する医療機器メーカー5.2 - 7.2 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- Our client is a leading multinational healthcare corporation that specializes in the sales and maintenance of medical equipment. In addition to offering consulting services for medical institutions, they leverage their expertise and utilize medical data to make significant contributions towards advancing the field of medicine.
- Responsibilities
- 【医療機器業での薬事・品質・開発等の実務経験をお持ちの方へ／フルフレックス／年休125日以上／グローバルで活躍する医療機器メーカー】
■業務内容：薬事部のスペシャリストとして、日本における製品導入計画を遅滞なく達成できるよう担当製品のライセンスを取得し、日本におけるビジネスの目標達成に貢献する
薬機法やその他の要求事項について理解し、担当製品のライセンスの維持に貢献する
■業務詳細：日本の法規制に従い、担当製品の許認可等の取得を行う
日本の法規制を遵守する
新規の業許可取得又は変更のための書類を作成する
製品変更について評価を行い、必要に応じて薬事申請等の対応を行う
担当分野の製品のライセンスの取得に必要な臨床試験のマネジメントを行う
■任務：上長の指導の下、製造元及び関係各部署と連携し、製品導入等の業務を進める
担当製品のライセンスを取得又はそのサポートを行う
担当製品の変更や事業所の変更に対する対応又はそのサポートを行う
行政当局と良好な関係を構築する
担当分野の製品の臨床試験の実施・立案、及び認可取得に使用する海外で実施された臨床試験の対応を行う
■社風とキャリア：部署内外問わずフランクなコミュニケーションを取ることができ、何か困りごとがあれば気軽に相談できる環境です。また、「社内公募制度」もあるため、ご自身のキャリアに制限をかけることなく様々なことにチャレンジいただけるのも同社の魅力です。
Takahisa Hitotsumatsu
Industrial & Life Science -
Job number: JN -072024-168987 Posted: 2025-06-19
中近東・アフリカ向け海外営業
海外営業もしくは駐在経験をお持ちの方必見です。5 - 6.5 million yen Tokyo Medical Device Sales
- Company overview
- Out client is mainly engaged in the export of automobiles.
- Responsibilities
- 中近東・アフリカ向け海外営業をお任せします。
中近東・アフリカでの顧客開拓がメイン業務になります。
Shotaro Tsubaki
Industrial & Life Science -
Job number: JN -062025-189363 Posted: 2025-06-16
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
Go Ozawa
Industrial & Life Science -
Job number: JN -072024-32242 Posted: 2025-06-16
Clinical Marketing TMTT
新規事業部のClinical Marketing6 - 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
Shotaro Tsubaki
Industrial & Life Science -
Job number: JN -072024-25913 Posted: 2025-06-16
Regulatory Affairs Specialist
Global pioneer in healthcare industry7 - 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.
Go Ozawa
Industrial & Life Science -
Job number: JN -072024-33523 Posted: 2025-06-16
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.
Shotaro Tsubaki
Industrial & Life Science -
Job number: JN -072024-34143 Posted: 2025-06-16
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.
Shotaro Tsubaki
Industrial & Life Science -
Job number: JN -112024-179334 Posted: 2025-06-16
Product Manager PI_
Commit to both personal and professional commitments10 - 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.
Risa Harada
Industrial & Life Science -
Job number: JN -042025-187215 Posted: 2025-06-16
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
Industrial & Life Science -
Job number: JN -072024-30044 Posted: 2025-06-16
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
Industrial & Life Science -
Job number: JN -072024-34389 Posted: 2025-06-16
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
Shotaro Tsubaki
Industrial & Life Science -
Job number: JN -052025-189088 Posted: 2025-06-16
Product Manager (Marketing)
Improve lives through innovation & collaborative teamwork6 - 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.
Elaine Montes
Industrial & Life Science -
Job number: JN -032025-185457 Posted: 2025-06-16
Regulatory Affairs Specialist | 薬事スペシャリスト
Inclusive and collaborative work place5 - 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.
Elaine Montes
Industrial & Life Science -
Job number: JN -052025-188968 Posted: 2025-06-16
Senior Safety Control Specialist
Advance surgery, empower teams, and change lives7.6416 - 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
Elaine Montes
Industrial & Life Science -
Job number: JN -052025-188955 Posted: 2025-06-16
Quality Assurance Specialist (Product Quality)
Advance robotic-assisted surgery w/ cutting-edge innovation6.4345 - 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.
Elaine Montes
Industrial & Life Science -
Job number: JN -072024-169637 Posted: 2025-06-16
【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
Industrial & Life Science -
Job number: JN -062025-189318 Posted: 2025-06-16
【愛知県小牧市】医療機器品質管理・薬事申請＜スペシャリスト＞
医療機器等の品質管理経験者必見です!5 - 5.94 million yen Aichi Medical Device Regulatory Affairs (RA)
- Company overview
- Our client is an optical component manufacturer.
- Responsibilities
- 本ポジションでは、各国医療機器規制対応の為の薬事管理業務全般をお任せします。ISO 13485に基づくQMS維持管理、EU MDR移行申請、US FDA 510(k)申請及び国内製品認証申請の対応などもご担当いただきます。
業務詳細:
各国医療機器規制に則った製品認証の取得および維持管理業務
顧客からの品質問題に関する問い合わせ対応（リコール関連手続き含む）
品質向上に向けた製造工程での課題の抽出、解決方法の検討と運用など
Go Ozawa
Industrial & Life Science