Work Schedule Other Environmental Conditions Office Job Description 職務内容: 医療機器、体外診断用医薬品、動物用医薬品、研究用試薬（消耗品、機器含む）に係る薬事対応業務 ・製造販売業の維持・管理（更新申請手続き等、3役会議事務局運営など） ・販売店が保有する高度医療機器販売業・貸与業、医薬品販売業、動物用医薬品卸売販売業の管理 ・QMS適合性調査申請（承認前調査/定期調査） ・外国製造業者認定・登録の維持・管理 ・QMS内部監査対応（被監査部門への監査の実施、報告書作成保管等 1回/年） ・GVP対応（情報収集、当局報告、記録書作成保管等） ・薬事トレーニングの実施管理（年間計画の立案、トレーニング資料作成、e-learning等での実施、記録書作成保管等） ・プロモーションマテリアルレビューの管理 ・海外拠点及び顧客からの問合せ対応 必要とされる資格・経験 ・医薬品、医療機器、又は体外診断用医薬品分野におけるRAQAでの業務経験（1年以上） ・薬事規制（特に安全管理業務）に関する知識 ・当局対応経験 ・海外とコミュニケーションを行う英語力（メール対応） ・基本的なPCスキル（Word、Excel（表計算・グラフ作成）、PowerPoint） 歓迎される資格・経験 ・規制当局又は認証登録機関によるQMS適合性調査・ISO13485調査対応経験 ・安全性に関わる業務経験 ・ドキュメント管理システムの使用経験 ・製造販売業の三役の経験 Thermo Fisher Scientific Inc. is
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Are you an ambitious and proven business development executive with a passion for driving growth? Thermo Fisher Scientific Inc. is seeking a Sr. Business Development Executive -
Job Posting Title: Specialist - General Administration Division Req ID: 10092878 Job Description: Specialist Job Role: The Specialist for the General Administration Division at Walt Disney Attractions Japan is responsible for three main areas: Corporate Social
企業概要 ETAS Japan Established in October 1998. ETAS Japan is a 100-percent subsidiary of the ETAS GmbH. ETAS provides vehicle basic software, middleware, development tools, cloud-based operations services, cybersecurity solutions, and end-to-end engineering and consulting services
Job Description レゴ・グループの成長を共に牽引し、多くの子供たちにレゴの楽しさを届けていくためのエキサイティングな挑戦にぜひご参加ください! レゴグループでは Senior Demand Planning Manager を募集しています。 興味のある方は、以下のリンクから採用情報にアクセスください。 皆様の応募を心から楽しみにしております。 Are you detailed and strategic leader who enjoys building a trusted network within both the Markets and Channels & Operations? Bring the demand planning expertise
At Broadridge, weve built a culture where the highest goal is to empower others to accomplish more. If you’re passionate about developing your career, while helping others along the way, come join the Broadridge team. The
Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring
Are you enthusiastic about the opportunity of working for the global leader in renewable energy? Are you a constructive team member and want to be a part of an award-winning team, where the values are high?
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
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At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
About Agoda Agoda is an online travel booking platform for accommodations, flights, and more. We build and deploy cutting-edge technology that connects travelers with more than 3.6 million accommodations globally. Based in Asia and part of
We are seeking an experienced creative and passionate copywriter to join our Growth Creative Team at Crypto.com. This role will work closely with our Creative Director to develop engaging and visually appealing digital content across various
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After 10 years of continuous growth, Janssen Japan (JPKK) business is faced with two years of solid growth in 2024 and 2025. This is an important period to ensure successful delivery of our performance goals. As
Who we are About Stripe Stripe is a financial infrastructure platform for businesses. Millions of companies—from the world’s largest enterprises to the most ambitious startups—use Stripe to accept payments, grow their revenue, and accelerate new business
This position requires English language ability. JD is available in English only. 本ポジションは日本語JDの用意がありません。 Introduction Circulate all forms of value to unleash the potential in all people What can I do to help society thrive with the
Woven by Toyota is the mobility technology subsidiary of Toyota Motor Corporation. Our mission is to deliver safe, intelligent, human-centered mobility for all. Through our Arene mobility software platform, safety-first automated driving technology and Toyota Woven
Job Description Overview We are seeking a skilled and experienced Site Reliability Engineer to join our team. In this role, you will be part of the AI & Cloud Engineering (ACE) Division and AI Workbench team.
Are you an experienced medical professional and passionate about Medical Affairs? Are you a dynamic leader with a passion for driving MSL team? If so, we have an exciting opportunity for you to join our team
