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600万円以上、1600万円以下 の求人情報一覧

3998
621~640件 を表示
  • 求人番号:JN -062025-189363 掲載日: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
    600 - 1000 万円 東京 医療機器 臨床研究 / 臨床開発

    会社概要
    当社は、日本を拠点とする大手企業で、幅広い製品やサービスを提供しています。写真フィルムやカメラだけでなく、医療機器や化学製品、光学機器なども手掛けています。製品の品質や革新性、持続可能性に焦点を当て、世界中で顧客に価値を提供しています。また、研究開発にも力を入れ、科学技術の進歩に貢献しています。
    業務内容
    【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
    Go Ozawa
    Industrial & Life Science
  • 求人番号:JN -062025-189661 掲載日:2025-06-16

    内部監査

    海外に駐在した経験がある方必見です。
    800 - 1300 万円 東京 経理&財務 監査 / リスク

    会社概要
    同社は、損害保険会社です。
    業務内容
    コンプライアンス態勢整備へ向けた企画・立案(海外コンプラ関連の規程整備、コンプライアンス・プログラムの策定)
    コンプライアンス事項に関する支援・指導

    Maria Nakata
    Maria Nakata
    Corporate Services
  • 求人番号:JN -032025-185392 掲載日:2025-06-16

    お米の輸入・調達

    営業や購買等の交渉、折衝経験をお持ちの方必見です
    732 - 781 万円 東京 サプライチェーンマネジメント 輸出入

    会社概要
    同社は、農林水産省が実施する輸入米穀の入札に参加する資格を持つ指定商社です。
    業務内容
    同社は、農林水産省が実施する輸入米穀の入札に参加する資格を持つ指定商社です。本ポジションの方には、年間を通じて行われる競争入札に参加し、アメリカやタイなど世界各国から米を輸入・調達する業務を担当していただきます。関係各所との条件交渉や入札価格の設定など、数値の読み解きも重要な業務となります。【仕事の流れ】公開された入札に関する情報の収集・整理(コメの品種、数量、仕入れ先の国、到着港など)
    仕入れ先である海外大手精米輸出業者との交渉
    輸送用船舶の手配/船舶会社との調整・交渉
    国内物流の手配/港湾運送業者、倉庫業者の調整・交渉
    適正な入札価格の算出/応札
    落札後、本邦の港に到する着までの工程管理
    農林水産省への売却・最終受渡し
    Emmeline Tang
    Emmeline Tang
    Industrial & Life Science
  • 求人番号:JN -052025-188611 掲載日:2025-06-16

    事業推進

    グローバル企業とのアライアンス戦略の企画・推進経験をお持ちの方必見です
    800 - 1200 万円 東京 営業&マーケティング 事業開発 / 営業

    会社概要
    同社は、モバイル決済サービスを提供する会社です。スマートフォンアプリを通じて、消費者が簡単に電子決済や送金を行える仕組みを提供しています。特に、QRコード決済やデジタルウォレットの利用を推進し、店舗やオンラインでの決済手段として広く利用されています。安全性と利便性を重視し、ユーザーが安心して利用できる環境を整えています。また、様々なキャンペーンや特典を通じて、ユーザーの利便性を高める取り組みを行っています。経済活動の活性化や消費者の生活の利便性向上を目指し、日本国内でのキャッシュレス社会の実現に貢献しています。
    業務内容
    同社は更なる事業拡大を目指し、各業界をリードするグローバル企業との戦略的提携に注力して参ります。グローバルな視点で新たなパートナーシップの創出に挑戦し、その中核メンバーとして国際戦略の立案および事業推進を担っていただける方、”未来の金融サービス”を共に切り拓いていただける方を募集いたします。【具体的な業務内容】戦略的提携の企画立案
    ターゲット企業のリサーチ、発掘およびアプローチ
    提携候補企業との交渉・契約締結
    提携プロジェクトの推進・管理
    社内外の関係者との連携・調整
    Maria Nakata
    Maria Nakata
    Corporate Services
  • 求人番号:JN -062025-189727 掲載日:2025-06-16

    【東京】労務スペシャリスト(マネージャー候補)

    業界未経験者歓迎です!
    600 - 900 万円 東京 人事 給与 / 社会保険

    会社概要
    *同社の特徴

    - コンサルティングの“スキル”よりも、コンサルタントという“人”に焦点を当てることを重視
    - 創業から社員が一丸となり、クライアントの本当に求めていることを考え、迅速に対応

    *事業領域

    ・デジタルコンサルティング:最新技術を活用してイノベーションや顧客体験の向上を支援
    ・ビジネスコンサルティング:非IT領域での業務改善や戦略策定を担当
    ・ITコンサルティング:戦略からオペレーションまで幅広くサポート
    ・プロジェクトマネジメント:プロジェクトの成功に向けた管理と支援を提供
    業務内容

    コンサルティングサービスを提供する企業にて労務マネージャーとしてご活躍いただける方を募集しています。
    業界未経験者歓迎です! 
    入社後は、OJTを通じて徐々に仕事に慣れていただき、労務業務の効率化・高度化を進めていただければと思います。
    まずは労務の業務を中心にお任せしますが、意欲や志向次第では、その他の管理部門の業務にも幅広く携わることができます。 
    <主な仕事内容>給与計算および社会保険事務(外部専門家と連携)
    労働時間管理
    入社・異動・休職者管理
    安全衛生
    有期雇用社員・障碍者雇用の契約管理
    官公庁への届出
    人事関連規程・労使協定管理


    ━━━━━━━━━━━━━━━#spotlightjob5
    Nao Yoshida
    Nao Yoshida
    Corporate Services
  • 求人番号:JN -072024-32242 掲載日:2025-06-16

    Clinical Marketing TMTT

    新規事業部のClinical Marketing
    600 - 900 万円 東京 医療機器 マーケティング

    会社概要
    同社は日本の医療機器メーカーで、グローバル・メディカルカンパニーとして患者の生活の質向上を目指しています。重度の循環器疾患治療・測定用医療機器の開発・製造・販売・サービスを手掛け、特に弁膜症治療に使用される人工心臓弁や弁形成術製品、また血行動態モニタリングなどのクリティカルケア製品では世界のトップシェアを誇っています。また、環境保護、社会貢献、企業ガバナンスの責任を重視し、持続可能な取り組みを推進しています。医療従事者向けのサポート情報や教育ツールの提供にも力を入れており、世界中で活動しています。
    業務内容
    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
    Shotaro Tsubaki
    Industrial & Life Science
  • 求人番号:JN -072024-25913 掲載日:2025-06-16

    Regulatory Affairs Specialist

    Global pioneer in healthcare industry
    700 - 1000 万円 東京 医療機器 薬事

    会社概要
    同社は医療機器の開発と販売を専門としています。主に心血管、泌尿器、消化器などの分野で使用される高度な医療機器を提供しており、患者の治療や診断を支援します。革新的な技術と研究開発を重視し、医療現場のニーズに応える製品を次々と市場に投入しています。製品ラインナップには、カテーテルやステント、内視鏡機器などがあり、高い品質と安全性を誇ります。また、医療専門家との協力を通じて、効果的な治療法の普及と医療技術の向上を目指しています。患者の生活の質向上をミッションに掲げ、グローバルなネットワークを活用して、世界中の医療機関に優れたソリューションを提供しています。
    業務内容
    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
    Go Ozawa
    Industrial & Life Science
  • 求人番号:JN -072024-33523 掲載日:2025-06-16

    Safety Specialist

    理系卒未経験の方歓迎
    600 - 1000 万円 東京 医療機器 品質保証 / 品質管理

    会社概要
    手術システムメーカーです。特に低侵襲手術に力を入れており、パイオニア的存在です。
    業務内容
    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
    Shotaro Tsubaki
    Industrial & Life Science
  • 求人番号:JN -072024-34143 掲載日:2025-06-16

    CRD x Ambassador

    営業リードの獲得にご興味ある方
    700 - 1000 万円 大阪 医療機器 営業

    会社概要
    同社は様々な製品を提供する世界有数の医薬品、健康管理事業を行っている米国企業の日本法人です。
    診断薬・機器、医薬品、病院用製品、栄養剤など多彩な製品群を持ち、診断から治療まで広範囲にカバーする高品質・高機能の製品とサービスを提供し、高い評価を得ています。もちろん部門間での異動や情報共有もされており、総合ヘルスケアメーカーとして圧倒的な地位を築いています。
    業務内容
    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
    Shotaro Tsubaki
    Industrial & Life Science
  • 求人番号:JN -112024-179334 掲載日:2025-06-16

    Product Manager PI_

    Commit to both personal and professional commitments
    1000 - 1400 万円 東京 医療機器 マーケティング

    会社概要
    同社は、医療技術(メドテック)分野のグローバル企業です。医療機器、研究設備、診断製品、薬剤管理や感染予防などの医療ソリューションを強みとして医療従事者から親しまれています。
    業務内容
    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
    Risa Harada
    Industrial & Life Science
  • 求人番号:JN -042025-187215 掲載日:2025-06-16

    Lead Regulatory Affairs Specialist (Project Leader), Japan

    Leading medical device manufacture
    800 - 1000 万円 東京 医療機器 薬事

    会社概要
    同社は医療機器、医療画像処理機器、診断機器、生命科学関連機器などを提供する大手メドテック企業です。診断、治療、ヘルスケアの向上を支援するための製品やソリューションを提供しており、総合的な医療技術および診断の領域で活動しています。
    業務内容
    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
    Takahisa Hitotsumatsu
    Industrial & Life Science
  • 求人番号:JN -072024-30044 掲載日: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!
    700 - 900 万円 東京 医療機器 マーケティング

    会社概要
    同社は、医療機器の輸入と販売を主な事業とし、循環器系疾患の検査および治療用デバイスを提供しています。また、神経外科領域にも進出し、新たな事業分野として取り組んでいます。同社の使命は、世界中の心臓病や神経系、慢性疼痛の患者の治療に携わる医療従事者が優れた治療手段を手に入れることを支援することです。リスクの軽減と全ての患者の治療の成功に貢献し、医療技術とサービスの開発に注力しています。
    業務内容
    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
    Shotaro Tsubaki
    Industrial & Life Science
  • 求人番号:JN -072024-34389 掲載日:2025-06-16

    Marketing Communication

    顧客Facingな仕事がしたい方歓迎です
    800 - 1100 万円 東京 医療機器 マーケティング

    会社概要
    同社は日本の医療機器メーカーで、グローバル・メディカルカンパニーとして患者の生活の質向上を目指しています。重度の循環器疾患治療・測定用医療機器の開発・製造・販売・サービスを手掛け、特に弁膜症治療に使用される人工心臓弁や弁形成術製品、また血行動態モニタリングなどのクリティカルケア製品では世界のトップシェアを誇っています。また、環境保護、社会貢献、企業ガバナンスの責任を重視し、持続可能な取り組みを推進しています。医療従事者向けのサポート情報や教育ツールの提供にも力を入れており、世界中で活動しています。
    業務内容
    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
    Shotaro Tsubaki
    Industrial & Life Science
  • 求人番号:JN -082024-173752 掲載日:2025-06-16

    Senior specialist/manager, Regulatory Affairs

    勤務地は東京or大阪(リモートワーク有)
    700 - 900 万円 東京 医療機器 薬事

    会社概要
    同社は、医療技術(メドテック)分野のグローバル企業です。医療機器、研究設備、診断製品、薬剤管理や感染予防などの医療ソリューションを強みとして医療従事者から親しまれています。
    業務内容
    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.

    ━━━━━━━━━━━━━━━#poweredjob3
    Risa Harada
    Risa Harada
    Industrial & Life Science
  • 求人番号:JN -052025-189088 掲載日:2025-06-16

    Product Manager (Marketing)

    Improve lives through innovation & collaborative teamwork
    600 - 900 万円 東京 医療機器 マーケティング

    会社概要
    同社は、外資系医療機器メーカーです。
    業務内容
    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
    Elaine Montes
    Industrial & Life Science
  • 求人番号:JN -052025-188968 掲載日:2025-06-16

    Senior Safety Control Specialist

    Advance surgery, empower teams, and change lives
    764.16 - 1100 万円 東京 医療機器 薬事

    会社概要
    手術システムメーカーです。特に低侵襲手術に力を入れており、パイオニア的存在です。
    業務内容
    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
    Elaine Montes
    Industrial & Life Science
  • 求人番号:JN -052025-188955 掲載日:2025-06-16

    Quality Assurance Specialist (Product Quality)

    Advance robotic-assisted surgery w/ cutting-edge innovation
    643.45 - 900 万円 東京 医療機器 品質保証 / 品質管理

    会社概要
    手術システムメーカーです。特に低侵襲手術に力を入れており、パイオニア的存在です。
    業務内容
    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
    Elaine Montes
    Industrial & Life Science
  • 求人番号:JN -072024-169637 掲載日: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!
    700 - 1300 万円 東京 医療機器 マーケティング

    会社概要
    医療・健康関連製品を提供する世界的な医療機器・製薬会社です。医薬品、医療機器、消費財などの製品を取り扱い、健康な生活を支援するさまざまな製品を提供しています。特に、医療技術や研究開発への投資を通じて、先進的な医療ソリューションを提供し、医療の質と効率を向上させています。また、教育や啓発活動を通じて、社会の健康意識を高め、より良い未来の実現に貢献しています。
    業務内容
    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
    Takahisa Hitotsumatsu
    Industrial & Life Science
  • 求人番号:JN -072024-144139 掲載日:2025-06-16

    [Janssen] Contract & Compliance Services, Site Engagement Analyst

    Open to CRO CRA Candidates
    600 - 900 万円 東京 製薬 臨床開発

    会社概要
    同社は、世界的な製薬企業の一部であり、医療・健康分野に特化した製品とサービスを提供しています。主に医薬品の研究開発、製造、販売を行い、疾病の治療や予防に貢献しています。革新的な医療技術と科学的アプローチに基づき、高度な研究と開発を進め、新たな治療法や医薬品を市場に提供しています。また、医療従事者や患者への教育活動や支援プログラムも展開し、医療の質の向上に寄与しています。グローバルに展開するネットワークを活かし、多様な地域と市場でのニーズに応え、持続可能な医療イノベーションを推進しています。
    業務内容
    Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations.
    Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
    Participate in discussions related to the development of site/investigator budgets aligned with fair market value.
    Manage the contract amendment lifecycle.
    Assume responsibility for all aspects of legal document and metrics tracking.
    Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
    Comply with requests from QA and auditors.
    Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
    Work with the global CCS team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions. Escalate issues as appropriate.
    Exemplary customer focus with vision to drive solutions
    Patrick Chang
    Patrick Chang
    Industrial & Life Science
  • 求人番号:JN -072024-137933 掲載日:2025-06-16

    QA Manager

    QA Manager
    1000 - 1200 万円 東京 製薬 品質保証 / 品質管理

    会社概要
    は、日本国内において医療技術の研究開発と提供を行っています。特に、革新的な治療法の開発に注力し、がん治療に関する先端的な技術を提供しています。光免疫療法という新しい治療アプローチを用いて、がん細胞を標的とした効果的な治療を目指しています。この技術は、光と薬剤を組み合わせることで、選択的にがん細胞を破壊することが可能です。研究開発においては国内外の専門機関や大学との連携を強化し、臨床試験や実用化に向けた取り組みを進めています。医療分野における革新と患者の生活品質向上を目指し、日々努力しています。
    業務内容
    Support Quality Assurance supervisor to achieve Japan Commercial Operations objectives from Medical device and drug perspective.
    When Quality Assurance issue arises, lead to define the appropriate Quality measurement through the communication with the related internal, global and external parties.
    Ensure full compliance with applicable regulations in Japan.
    Oversee all activities or responsibilities that are delegated to external parties.
    Martin Tsvetkov
    Martin Tsvetkov
    Industrial & Life Science

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