- Support QMS conformity survey application.
- In charge of class I to III medical device application.
- Support other teams.
- Be a part of mega device company.
- Multiple options for career progression.
- Medical Device regulatory application experience.
- Fluent level Japanese and business level English language ability.
- Should be able to apply and review documents & answer inquires in Japanese.
- Authorized to work in Japan.
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Medtronic Tokyo, 日本JOB TITLE: 薬事スペシャリスト · DEPARTMENT: 品質保証・薬事 薬事 Cardiovascular/DIB ポートフォリオ · REPORTING TO:MANAGER · ********************************************************************************************** · Main Mission of Job · "Being a "bridge" to deliver "meaningful" medical device t ...
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Philips Tokyo, 日本 フルタイムJob Title · Regulatory Affairs ManagerJob Description · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. ...
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Philips Tokyo, 日本 フルタイムJob Title · Regulatory Affairs Manager (SRC)Job Description · Job title: · Regulatory Affairs Manager · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innova ...
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Philips Tokyo, 日本 フルタイムJob Title · Regulatory Affairs ManagerJob Description · Job title: · Regulatory Affairs Manager · Your role: · Exciting opportunity to play an integral role in introducing new product/solution, maintain regulatory compliance and leading transformation/improvement activities. · De ...
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Philips Tokyo, 日本 フルタイムJob Title · Regulatory Affairs SpecialistJob Description · 職務説明 · Exciting opportunity to support introducing new product/solution, maintain regulatory compliance and actively participate transformation/improvement activities. · 新製品やソリューションの導入をサポートし、規制コンプライアンスを維持し、フィリップスの変革/改善活動に ...
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イーピーエス(株) Tokyo, 日本医薬品の製造と品質管理に関する分野の薬事業務を担当いただきます。 · 医薬品の製造方法と品質試験方法に関する資料作成の経験を豊富に得ることが出来ます。 · ・マスターファイル(MF)の作成・登録と、登録後の変更対応 · ・外国製造業者認定取得・更新と認定期間中の変更対応 · ・GMP適合性調査のサポート業務 · ・CTD Module 2.3及び承認申請書の作成 · ・PMDA相談資料の作成及び相談の実施 · ・薬事規制の情報収集及び海外顧客への説明 ...
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Philips Tokyo, 日本 フルタイムJob Title · Regulatory Affairs ManagerJob Description · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. ...
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Philips Tokyo, 日本 フルタイムJob Title · Regulatory Affairs Senior Manager - IGTDJob Description · Regulatory Affairs Senior Manager · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through inno ...
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Philips Tokyo, 日本 フルタイムJob Title · Regulatory Affairs Senior ManagerJob Description · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better to ...
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Fortive Tokyo, 日本 フルタイムPosition Summary · The Senior Regulatory Affairs Specialist (Sr, RA Specialist) is responsible for developing regulatory strategies, preparing Local submissions and supporting international submissions to obtain and maintain approval/certification for drug/device products and the ...
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Cargill Tokyo, 日本Job Purpose · and Impact The Industrial Chemical Regulatory Specialist II will ensure compliance with government chemical regulations or standards in the areas of product compliance, hazard communication, customer documentation and other regulatory functions. In this role, you w ...
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BioMarin Tokyo, 日本 フルタイム-RegularJOB DESCRIPTION · Job Title: · Associate Director, Regulatory Affairs Japan · Department / CostCenter: · Regulatory – 210 · Reports to (Job Title): · Head of APAC Regulatory Affairs · Job Code: · Location: · Tokyo · Date Prepared: · April 2024 · Full-Time Part-Time · Regular Te ...
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Guerbet Tokyo, 日本 Long-term/regularDescription · 1. General Marketing Compliance Officer (SOKATSU-SEKININSHA) Responsible to assure compliance with GVP and GQP through supervision and instruction to safety manager and quality assurance manager. Must report issues and risks to the MAH. Name and address are registe ...
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Biogen Tokyo, 日本 フルタイムJob Description · Responsible for all activities of Japan regulatory operations as a lead of regulatory operation in collaboration with Global RA, Japan R&D, and other functional areas within Biogen. · Manage and maintain regulatory operational activities in drug development, ND ...
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Jazz Pharmaceuticals Chiyoda, 日本 フルタイムJOB PURPOSE · The Manger, Regulatory Affairs, Japan shall manage regulatory activities assigned in GW Pharma order to obtain new drug application(NDA) approval, partial change application(PCA) approval, to submit appropriate minor change notification(MCN) and to execute other ne ...
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Advanced Sterilization Products Koto City, 日本 フルタイムresponsibilities · . §Related Regulatory and/or Quality Assurance experience. · Nice to Have: · 5+ years medical device industry experience. · Advanced degree in a scientific discipline (engineering, physical/biological or health sciences). · New product development experience ...
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Philips Tokyo, 日本 フルタイムJob Title · 【2025年新卒】Regulatory Affairs SpecialistJob Description · 職務説明 · Exciting opportunity to support introducing new product/solution, maintain regulatory compliance and actively participate transformation/improvement activities. · 新製品やソリューションの導入をサポートし、規制コンプライアンスを維持し、フィリップス ...
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ICONクリニカルリサーチ(同) Tokyo, 日本ICONのRegulatory Affairs部門では、治験届業務のみにとどまらず、CMCを含めたコンサルとオペレーションご経験いただけます。また、今後は申請業務も受託していく見込みです。 · Project内容としても、ICCCとメガファーマ、製薬・医療機器含めて多岐にわたり、広いご経験を積んでいただくことができます。 · 薬事の実務業務(60%)およびチームメンバーのマネジメント業務(40%)を担っていただきます。 · ※業務内容詳細はフリーコメント欄へ ...
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RA Specialist
5日前
Thermo Fisher Scientific Tokyo, 日本 フルタイムDevelop and implement regulatory strategy across projects to ensure that company products are safe, legal and meet expectations with regulations. · Maintain and improve upon processes to ensure compliance with required regulatory standards and governing bodies. · Prepare document ...
Regulatory Affairs - Tokyo, 日本 - Cornerstone Recruitment Japan
説明
【COMPANY OVERVIEW】
An American mega device company with more than 50 years of history of establishment.
【JOB RESPONSIBILITIES】
【WHY YOU SHOULD APPLY】
【REQUIREMENTS】
