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  • Job number: JN -072024-149604 Posted: 2024-09-11

    Quality Control | 品質管理

    高クラス医療機器の品質管理・将来的にマネジメント業務も担っていただく可能性あり
    5 - 7 million yen Tokyo Medical Device Quality Assurance / Quality Control

    Company overview
    Our client is a medical device manufacturer.
    Responsibilities
    メディカル部門の品質管理担当者として以下の業務に従事いただきます。
    業務内容:
    ガイドワイヤー、カテーテル等の弊社ブランド製品の品質管理業務品質管理
    変更管理
    不適合品管理
    計測器管理
    評価
    データ分析
    改善等

    滅菌プロセスの維持・管理各バリデーション
    法規制対応
    監査対応 等

    品質保証業務法規制対応
    監査対応 等

    開発プロセスにおけるQMS視点のチェック、管理
    医薬品医療機器等法、QMSに基づく記録の作成、管理

    ※ 将来的に現地でのマネジメント業務の可能性もあります※国内外転勤可能性ありますが、当面はございません。
    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -072024-150828 Posted: 2024-09-11

    Quality Assurance - Eye Care Products | アイケア関連製品における品質保証

    日系安定成長企業・顧客満足度を向上させる重要な役割を担っていただきます
    7 - 12 million yen Tokyo Medical Device Quality Assurance / Quality Control

    Company overview
    The company is a Japanese optical equipment manufacturer. It engages in the development, manufacturing, and sales of precision measurement equipment. Operating in various fields such as construction, agriculture, and healthcare, it provides surveying equipment and location-based technology. Particularly in the construction industry, it offers automatic control technology for construction machinery and surveying/geospatial information systems to support efficient construction operations. In the agricultural sector, it provides equipment for automatic control of agricultural machinery and devices for precision agriculture, contributing to increased productivity and environmentally conscious farming practices. Furthermore, it develops and provides medical equipment and technology, contributing to the realization of advanced healthcare.
    Responsibilities
    当社アイケア製品の品質保証に関する業務全般をお任せします。
    業務内容:
    苦情内容に関する調査・分析 
    苦情情報の調査・分析に関する品質改善指示
    苦情の是正と予防対応
    出荷停止及び解除に関する業務
    回収/改修に関する業務
    製造販売後の法規制に関する業務
    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -072024-150829 Posted: 2024-09-11

    Quality Assurance (Post-Marketing Surveillance) | 品質保証(市販後調査)

    高クラス医療機器の市販後調査・将来的に安全管理責任者としてご活躍いただける可能性有
    5 - 8 million yen Tokyo Medical Device Quality Assurance / Quality Control

    Company overview
    Our client is a medical device manufacturer.
    Responsibilities
    医療機器の市販後監視活動(PMS)安全管理業務(GVP)をご担当いただきます。
    業務内容:
    文献調査、クレーム分析、トレンド分析、類似医療機器の公開情報分析等
    安全管理業務(安全性情報収集・評価・分析)
    不具合に関する報告書の作成、国内外の行政機関に対する報告・対応
    各国の法規制への対応・各国の行政との折衝
    担当チームのマネジメント業務

    ※将来的には、安全管理責任者としての業務を行っていただく可能性があります。
    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -072024-8696 Posted: 2024-09-11

    Clinical Specialist

    メーカー未経験の放射線技師の方必見です
    7 - 11 million yen Tokyo Medical Device Clinical Specialist

    Company overview
    We are a Japanese medical device manufacturer aiming to improve patients\' quality of life as a global medical company. We develop, manufacture, sell, and service medical devices for the treatment and measurement of severe cardiovascular diseases, particularly excelling in artificial heart valves and valvuloplasty products for valve disease treatment, as well as critical care products like hemodynamic monitoring systems. We emphasize environmental protection, social contribution, and corporate governance responsibilities, promoting sustainable initiatives. Additionally, we provide support information and educational tools for healthcare professionals worldwide.
    Responsibilities
    新規治療デバイスに関し、医師およびコメディカルに対し製品の取扱い説明
    適正使用のための説明会・トレーニング等の運営
    社内関係部署に対してのトレーニング実施
    トレーニング資料・学会レポート作成
    Shotaro Tsubaki
    Shotaro Tsubaki
    Medical Device
  • Job number: JN -072024-151509 Posted: 2024-09-11

    Inside Sales | インサイドセールス

    AI医療製品・技術で世界を変える会社・副業可能
    5 - 7 million yen Tokyo Medical Device Sales

    Company overview
    Our client is a Japanese AI solutions company specializing in the healthcare sector. With expertise in medical data analysis and advanced AI algorithm development, they are dedicated to addressing key challenges in the healthcare field. Their solutions contribute to optimizing diagnostic support, treatment planning, and overall healthcare efficiency. Much of their investments go into the development of AI solutions for health-related applications, encompassing areas such as patient monitoring, predictive analytics, and overall health management/support.
    Responsibilities
    現在開発中のAI医療製品(内視鏡AI医療ソフトウェア)のマーケティング活動の反響に対する適切なコミュニケーションの構築、および商談化させるまでを担っていただきます。新規製品のブランディング・マーケティング活動の一部を担い、反響の内容をマーケティングチームにフィードバックし、より良いプロモーション活動を実現することも大きな役割となります。
    業務内容:
    Web、SNS、イベント、セミナー、DM、紹介などを通して弊社製品(内視鏡AI)に興味を持って頂いた顧客に対するニーズのヒアリング
    商談機会のアレンジ(訪問はアウトバウンドチームが行います)
    マーケティングチームへのフィードバック、改善提案等
    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -072024-36441 Posted: 2024-09-11

    Sales Enablement Manager

    癌領域の病理リーディングカンパニーでのマーケポジション
    12 - 14 million yen Tokyo Medical Device Sales

    Company overview
    We import and sell microscopes and related equipment manufactured overseas in Japan. With a heritage dating back about 170 years, we represent a leading German precision equipment company, offering top-quality microscopes and peripherals imported and sold domestically. Through several corporate mergers since our inception, we emerged in 1990 as Leica Microsystems, a prominent European manufacturer of scientific instruments. Utilizing microscopes and associated equipment, we address the increasingly sophisticated observation, measurement, and analysis needs in the fields of life sciences and industry, providing optimal system solutions for users.
    Responsibilities
    In collaboration with Local Marketing, Field Application and Field Service department, develop Sales strategies and manage progress towards sustainable revenue growth and profitability.Support field members within Sales Department to ensure prompt actions taken by them and continuously improve processes within the Department to increase Sales productivity.
    Main responsibilities:
    ・Work in close communication with local Marketing members・Create a field Marketing & strategic Selling plan for revenue growth and support execution.・Support the streamline processes within the Sales Department.・Identify Sales margin improvement opportunities, create improvement plan and lead implementation.・Support Customer Relation Management・Provide sales support and guidance to team for product positioning.・Develop & execute training programs for the sale team to enhance their productivity to sell products. (value prep. Testimonials)・Address customer concerns and issues in a professional and timely manner.・Act as a primary contact to address questions and inquiries regarding market related activities.・Development of Local Sales promotional campaigns & sales enablement tools (incl. value prep for the region)・Customer insights & Customer Visits・Local and customer facing activities – product communication like ship-hold, discontinuation, field safety・KOL management - all important customers・Establish Reference Site and Manage・Dynamic/reactive pricing to tenders・LCPQ・Support corporate iitiatives and manage task in accordance to promotion plan. Lead and direct Sales repto support with sales programs and corporate initiatives.・Support preparation for tender (material prep, dynamic/reactive pricing)
    Takahisa Hitotsumatsu
    Takahisa Hitotsumatsu
    Medical Device
  • Job number: JN -072024-36442 Posted: 2024-09-11

    Quality Assurance Specialist

    癌領域の病理リーディングカンパニーでのQAポジション
    8 - 11 million yen Tokyo Medical Device Quality Assurance / Quality Control

    Company overview
    We import and sell microscopes and related equipment manufactured overseas in Japan. With a heritage dating back about 170 years, we represent a leading German precision equipment company, offering top-quality microscopes and peripherals imported and sold domestically. Through several corporate mergers since our inception, we emerged in 1990 as Leica Microsystems, a prominent European manufacturer of scientific instruments. Utilizing microscopes and associated equipment, we address the increasingly sophisticated observation, measurement, and analysis needs in the fields of life sciences and industry, providing optimal system solutions for users.
    Responsibilities
    Main responsibilities:
    ・Both IVD and medical device MAH Quality responsible person(Hinseki).・Both IVD and medical device MAH manufacturing manager (Seizou Sekininsha).・Lead and support for collaborating with BU and SU stakeholders to manage quality issues including support for the administration of fileld actions (Recall) and reporting in complaint system.・To update QMS documents based on local regulation modification/new release.・To lead regular internal QMS meeting and management review meeting.・To support all related LBS license (MAH IVD/medical device, poisonous substance import,medical device maintanance etc.)・To support medical writing regarding both IVD and medical device STED.・To support PMDA consultation document preparation and preparation for answers of queries from PMDA.
    Takahisa Hitotsumatsu
    Takahisa Hitotsumatsu
    Medical Device
  • Job number: JN -072024-147699 Posted: 2024-09-11

    Clinical and Therapy Specialist TAVI

    最新機器のクリニカルセールス
    6 - 7.5 million yen Tokyo Medical Device Clinical Specialist

    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
    PROCTORING
    Achieve certification of clinical specialist status by following the training process and gaining case experience (one part of this training will be in abroad, in English)
    Provide technical support to clinicians during procedures
    Master and demonstrate procedural steps for all involved physicians and staff at sites
    Assist cath lab personnel with set-up and break-down for procedures and with product handling/inventory management
    Implement field-based physician and staff training programs
    Must understand PER process and provide related information and feedback in clear, complete manner
    Allocate the resource of Therapy specialist when necessary.

    SITE MANAGEMENT

    Collaborate with implanting centers to help optimize clinical outcomes for their patients.
    Facilitate communication among the heart team that must work together effectively to screen patients, procedure scheduling, and optimal clinical outcomes
    Manage logistics between implanting sites and dealers related to procedural support
    Develop action plans (weekly, monthly, quarterly) by analyzing case volumes at each site and other analytics, and discuss plans and issues with the management to help the organization achieve its sales goals
    Upon selection of the new accounts by the management team, oversee administrative process for new accounts and dealers including schedule management, inventory handling, expectation setting, contracting, and education of stakeholders.
    Identify future physician proctors and develop them
    Coordinate physician proctors to activate new centers

    PATIENT SELECTION

    Keep medical team informed about patient selection criteria, focusing on differentiation
    Share own experience with physicians to help them refine patient selection

    DATA DISSEMINATION

    Carry out messaging campaigns and data sharing as directed by Marketing or Training
    Maintain up-to-date knowledge through regular self-study and actively share information and updates with colleagues

    OTHERS

    Gathers primary intelligence and market data
    Enter case information and activity data in Salesforce.com and other potential planning and impact measurement platforms.
    Shotaro Tsubaki
    Shotaro Tsubaki
    Medical Device
  • Job number: JN -072024-150827 Posted: 2024-09-11

    医療機器の設計開発・薬事申請(臨床評価)

    自社製品開発に不可欠な専門人材になれる機会
    6 - 7.5 million yen Tokyo Medical Device Regulatory Affairs (RA)

    Company overview
    We are a leading Japanese manufacturer and distributor of medical devices and related products. We have a particularly strong reputation in the field of medical devices, such as catheters and artificial heart-lung machines, and we are expanding our business widely both domestically and internationally. We are also expanding into the fields of pharmaceuticals and blood systems, providing comprehensive medical solutions. We focus on innovation and quality control, and develop our products with patient safety and healthcare professionals\' convenience in mind. We aim to contribute to the development of healthcare from a global perspective and are actively involved in the realization of a sustainable society.
    Responsibilities
    カテーテル領域で使用される機器の臨床評価におけるプランの立案、実施、解析およびレポート作成をご担当いただきます。開発製品設計チームや薬事、臨床開発、品質保証部門などの複数部門と協力しながら、主担当として一製品のレポート作成までをお任せします。
    業務内容:
    評価対象機器について、臨床・非臨床データの収集および解析を行い、その結果が安全性および性能に関する法的要求事項に対して適合できているかどうか評価
    規制当局または認証機関へ報告
    臨床評価(Clinical Evaluation)
    市販後臨床フォローアップ評価(Post-market Clinical Follow-up Evaluation)
    EU-MDRおよびNMPAなど、関連法規に係る情報収集
    認証申請/更新または承認申請に係る報告書作成および照会対応

    Takahisa Hitotsumatsu
    Takahisa Hitotsumatsu
    Medical Device
  • Job number: JN -082024-173360 Posted: 2024-09-11

    粒子線がん治療装置(PBT)のフィールドエンジニア

    将来の現地試運転所長候補/大手G/在宅
    6.2 - 8.5 million yen Chiba Medical Device Service Engineer

    Company overview
    We provide tech solution products, inheriting numerous manufacturing equipment businesses and integrating trading and manufacturing functions to offer a wide range of products. Our business includes inheriting surface mount system business, LCD and hard disk-related manufacturing equipment business, and semiconductor post-process manufacturing equipment business, seamlessly integrating trading and manufacturing functions.
    Responsibilities
    ■業務内容:
    顧客からの注文、照会、および発注された品目または製品に関するご意見を受け付けて処理し、技術的な専門知識や製品用途(機能)を駆使して、顧客をサポートします。製品、製品の利用可能性、販売地域、および個々の顧客に関する技術的な知識を活用し、主要なコミュニケーションリンクを顧客に提供することが求められます。


    ※将来的な所長候補の採用です。

    ■職務詳細:
    装置納入時の試運転業務、及びその準備業務

    試運転対応地域は国内、北米、欧州、アジアで国内外問わず数ヶ月~数年単位の現地への出張や赴任があります。
    粒子線治療装置は、真空機器、加速器、X線機器、大型回転ガントリ、位置決めソフトなど様々な技術の組み合わせで成り立っており、適性を見て担当業務に従事頂きます。
    現地試運転組織は所長の他に数人のスタッフ(外注含む)で構成されており、まずは所長の下で担当者(将来の所長候補者)として準備・現地経験・試験経験・マネジメント経験を積んでいただき、その後試運転所長として現地赴任いただく予定です。

    【変更の範囲:会社の定める業務】

     
    Takahisa Hitotsumatsu
    Takahisa Hitotsumatsu
    Medical Device
  • Job number: JN -072024-38045 Posted: 2024-09-11

    品質保証部 国内品質システムチーム(業態チーム)

    日本を代表する医療機器メーカーの品質のHQ
    6 - 8.5 million yen Tokyo Medical Device Quality Assurance / Quality Control

    Company overview
    We are a leading Japanese manufacturer and distributor of medical devices and related products. We have a particularly strong reputation in the field of medical devices, such as catheters and artificial heart-lung machines, and we are expanding our business widely both domestically and internationally. We are also expanding into the fields of pharmaceuticals and blood systems, providing comprehensive medical solutions. We focus on innovation and quality control, and develop our products with patient safety and healthcare professionals\' convenience in mind. We aim to contribute to the development of healthcare from a global perspective and are actively involved in the realization of a sustainable society.
    Responsibilities
    当社製品における「均質」を達成するため、日本における製造販売業者である本社品質マネジメントシステムの維持改善を担当するアソシエイトを募集します。
    製造販売業者における適切な品質システムの運用のため、チームリーダーの指示の下、上記職務内容実行の実務を担う。
    業務内容:
    薬機法およびQMS省令、GQP省令等の国内法規制および本社に適用される各国法規制要求に適合した本社QMSの維持・改善を担う。
    本社QMSにおける内部監査・自己点検の実施、外部認証機関や規制当局による本社への監査・査察の対応の全体調整を担う。
    本社における品質文書・記録の維持管理を主管する。
    Takahisa Hitotsumatsu
    Takahisa Hitotsumatsu
    Medical Device
  • Job number: JN -072024-39181 Posted: 2024-09-11

    Quality Assurance (Eye Care Products) | 品質保証(アイケア関連製品)

    医療機器業界での品質経験が活かせます
    7 - 11 million yen Tokyo Medical Device Quality Assurance / Quality Control

    Company overview
    The company is a Japanese optical equipment manufacturer. It engages in the development, manufacturing, and sales of precision measurement equipment. Operating in various fields such as construction, agriculture, and healthcare, it provides surveying equipment and location-based technology. Particularly in the construction industry, it offers automatic control technology for construction machinery and surveying/geospatial information systems to support efficient construction operations. In the agricultural sector, it provides equipment for automatic control of agricultural machinery and devices for precision agriculture, contributing to increased productivity and environmentally conscious farming practices. Furthermore, it develops and provides medical equipment and technology, contributing to the realization of advanced healthcare.
    Responsibilities
    当社アイケア製品の品質保証に関する業務全般をお任せします。※将来的には、本人の希望も勘案し海外駐在も可能。
    業務内容:
    苦情の内容・傾向を調査・分析
    苦情情報の調査・分析結果に基づく品質改善の指示
    製造販売後の法規則に関する業務
    品質保証プロセスの監視
    新規製品および改良製品の試験・評価
    製造所の監視・監督
    主要販社品質保証部門に関する業務との情報連携
    Takahisa Hitotsumatsu
    Takahisa Hitotsumatsu
    Medical Device
  • Job number: JN -072024-148152 Posted: 2024-09-11

    【品質管理】医薬品原薬のGMP運用(管理職候補)◆GQPの取決め/チーム労務管理

    海外取引比率約60%・世界約90ヶ所の国や地域との取引実績あり/大手G中核企業
    10.2 - 13 million yen Tokyo Medical Device Quality Assurance / Quality Control

    Company overview
    Our client is an organic chemicals business company.
    Responsibilities
    ■業務概要:
    品質保証課の薬事MF担当として管理職候補としてご活躍いただき、下記業務をお任せします。

    医薬品倉庫の医薬品原薬のGMPの運用、管理(QRM、年次照査、GMP適合性調査査察対応、各種手順書および製品標準書の管理、GQPの取決め締結等)
    品質クレームへの対応
    当局および顧客からの査察対応

    ■入社後の業務:
    自社GMP運用に係る作業および管理業務(製造管理者、品質管理責任者、製造管理責任者等)
    課員の労務管理
    製販および当局の査察対応


    ■薬事部の特徴:
    医薬品の品質および安全性を確認する上で重要な品質管理業務については、自社で保有する試験室において海外の医薬品原料を厳密に試験し、安全且つ安定的に日本の製薬メーカーに供給できる体制を構築し信頼を得ています。

     
    Shotaro Tsubaki
    Shotaro Tsubaki
    Medical Device
  • Job number: JN -072024-147084 Posted: 2024-09-11

    【東京】医療機器の臨床治験マネージャー

    冠動脈治療用バルーンは国内シェアトップクラス
    8.5 - 11 million yen Tokyo Medical Device Product Engineering

    Company overview
    Our client is a global medical device manufacturer.
    Responsibilities
    医療機器治験(クリニカル)に関するプロジェクト全般のデータ管理

    - CROと協力して担当施設の症例進捗管理業務、Annual Report の作成

    - CRO と共にGCPを遵守するための手順書作成及び監督官庁への報告書作成

    - 冠動脈ステント治験に関する各種データ及び文書管理

    - 海外との連携により治験に関連する薬事対応・問題解決・進捗等のサポー・ト業務

    次世代冠動脈ステントの導入に関する業務
    将来的にはクリニカル以外にも、治験プロジェクトや市販後臨床試験等全体のマネージメントを実施
    Takahisa Hitotsumatsu
    Takahisa Hitotsumatsu
    Medical Device
  • Job number: JN -072024-149456 Posted: 2024-09-11

    Regulatory Affairs Senior Specialist | 薬事シニアスペシャリスト

    Class IV RAにご興味ある方が対象です
    7 - 9 million yen Tokyo Medical Device Regulatory Affairs (RA)

    Company overview
    We are a global medical devices and pharmaceutical company providing healthcare-related products. We offer a wide range of products including pharmaceuticals, medical devices, and consumer goods to support healthy living. Particularly, through investments in medical technology and research and development, we provide advanced medical solutions, enhancing the quality and efficiency of healthcare. Additionally, we contribute to raising awareness of health in society through education and outreach activities, aiming for a better future.
    Responsibilities
    日本国内で心臓アブレーション治療や脳血管治療関連の製品を展開しています。その薬事担当としてクラスIV機器の新製品導入・適応拡大といったチャレンジングな薬事申請及び既存製品の維持活動を主たる業務とするポジションです。
    業務内容:
    海外製造元、ビジネス部門、臨床部門、品質管理部門等と協業
    PMDA、MHLWとの交渉を成功に導くことで、承認取得から保険適用、製品発売、市販後の社内外のプロセスを完遂していただきます。
    CSS RA Headにレポートします
     
    Shotaro Tsubaki
    Shotaro Tsubaki
    Medical Device
  • Job number: JN -072024-149797 Posted: 2024-09-11

    Upstream Product Marketing | 上流プロダクトマネジメント

    大手アイケアメーカー・企画、提案力にさらに磨きをかけたい方必見です!
    5 - 12 million yen Tokyo Medical Device Marketing

    Company overview
    The company is a Japanese optical equipment manufacturer. It engages in the development, manufacturing, and sales of precision measurement equipment. Operating in various fields such as construction, agriculture, and healthcare, it provides surveying equipment and location-based technology. Particularly in the construction industry, it offers automatic control technology for construction machinery and surveying/geospatial information systems to support efficient construction operations. In the agricultural sector, it provides equipment for automatic control of agricultural machinery and devices for precision agriculture, contributing to increased productivity and environmentally conscious farming practices. Furthermore, it develops and provides medical equipment and technology, contributing to the realization of advanced healthcare.
    Responsibilities
    アイケア事業におけるアップストリームプロダクトマネジメントをお任せします。
    業務内容:
    担当商品に関するプロダクトマネジメント業務対象商品に関する市場調査
    対象商品に関する市場要望の調査、取り纏め
    ビジネス要求書の作成
    販売価格、販売数量のシミュレーションに基づくビジネスプランの作成
    商品企画・商品化決定・商品認定に関する提案資料の作成、及びサポート

    プロダクトミーティング等の開催事務局業務
    プロダクトマネジメントに際し、国内外の関係者とのコミュニケーション、状況把握、支援業務
    販売後の商品に対するフィードバック調査、改良提案
    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -072024-149798 Posted: 2024-09-11

    Clinical Development | 臨床開発担当

    再生医療の臨床開発 ・立ち上げフェーズ・医療機器
    5 - 9 million yen Tokyo Medical Device Clinical Trials / Clinical Development

    Company overview
    Our client is selling, importing and exporting pharmaceuticals and other products.
    Responsibilities
    医療機器(バイオマテリアル製品)の開発モニタリング業務を担っていただきます。
    業務内容:
    国内における臨床試験計画立案、試験進捗管理、プロトコール作成、総括報告書作成等の文書作成業務
    PMDA相談等のプロジェクト管理業務
    海外における臨床試験の計画立案、FDA相談、臨床試験実施および管理業務
    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -072024-150058 Posted: 2024-09-11

    Global Quality Assurance | グローバル品質保証

    日系安定成長企業・医療機器の品質保証・顧客視点に立って継続的に品質の改善を進めています
    8 - 12 million yen Tokyo Medical Device Quality Assurance / Quality Control

    Company overview
    The company is a Japanese optical equipment manufacturer. It engages in the development, manufacturing, and sales of precision measurement equipment. Operating in various fields such as construction, agriculture, and healthcare, it provides surveying equipment and location-based technology. Particularly in the construction industry, it offers automatic control technology for construction machinery and surveying/geospatial information systems to support efficient construction operations. In the agricultural sector, it provides equipment for automatic control of agricultural machinery and devices for precision agriculture, contributing to increased productivity and environmentally conscious farming practices. Furthermore, it develops and provides medical equipment and technology, contributing to the realization of advanced healthcare.
    Responsibilities
    当社アイケア製品の品質保証に関する業務全般をお任せします。
    業務内容:
    各販社のQMS遵守状況の確認
    各販社の苦情情報の傾向調査及びに品質改善
    苦情の是正と予防
    出荷停止および解除に関する業務
    回収/改修に関する業務 
    製造販売後の法規則に関する業務
    製造所の監視・監督に関する業務
    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -072024-149794 Posted: 2024-09-11

    Postmarketing Surveillance | 市販後調査

    品質保証のスペシャリストとしてご活躍いただきます!
    5 - 8 million yen Tokyo Medical Device Quality Assurance / Quality Control

    Company overview
    Our client is a medical device manufacturer.
    Responsibilities
    医療機器の市販後監視活動(PMS)安全管理業務(GVP)をお任せいたします。
    業務内容:
    文献調査、クレーム分析、トレンド分析、類似医療機器の公開情報分析等
    安全管理業務(安全性情報収集・評価・分析)
    不具合に関する報告書の作成、国内外の行政機関に対する報告・対応
    各国の法規制への対応・各国の行政との折衝
    担当チームのマネジメント業務

    ※将来的には、安全管理責任者としての業務を行っていただく可能性があります。※国内外の転勤の可能性はありますが、当面はございません。
    Go Ozawa
    Go Ozawa
    Medical Device
  • Job number: JN -072024-149795 Posted: 2024-09-11

    Complaint Handler | 苦情処理推進担当

    大手アイケアメーカー・品質保証での新たな取り組みをリードいただける方を募集いたします!
    5 - 9 million yen Tokyo Medical Device Quality Assurance / Quality Control

    Company overview
    The company is a Japanese optical equipment manufacturer. It engages in the development, manufacturing, and sales of precision measurement equipment. Operating in various fields such as construction, agriculture, and healthcare, it provides surveying equipment and location-based technology. Particularly in the construction industry, it offers automatic control technology for construction machinery and surveying/geospatial information systems to support efficient construction operations. In the agricultural sector, it provides equipment for automatic control of agricultural machinery and devices for precision agriculture, contributing to increased productivity and environmentally conscious farming practices. Furthermore, it develops and provides medical equipment and technology, contributing to the realization of advanced healthcare.
    Responsibilities
    アイケア品質保証課の苦情処理推進担当(またはエキスパート)として以下の業務を担っていただきます。
    業務内容:
    アイケア製品の品質向上を目的とした、製品の開発から市販後まで幅広い品質監視業務全般
    市販前に苦情となりうる製品の問題を抽出し、改善させ、苦情率を低下させる
    製品品質に悪影響を及ぼす要因が無いか、ユーザー施設に製品を持ち込み、エンドユーザーの意見を取り入れ、製品に反映する
    市販前/後の製品評価業務をリード
    Go Ozawa
    Go Ozawa
    Medical Device

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