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
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
AVEVA is a global leader in industrial software. Our cutting-edge solutions are used by thousands of enterprises to deliver the essentials of life – such as energy, infrastructure, chemicals and minerals – safely, efficiently and more
AI Sales, Business Development Executive At Dell Technologies, we create the extraordinary. Our AI Sales Biz Dev Executives are the experts who sell AI innovation to the world. Responsible for AI business growth & sales enablement,
Our client’s Microsoft Business Solutions team is a Microsoft Gold Partner and leader in Microsoft software implementations for medium to large organizations, providing their clients with the ability to keep up with the ever-changing digital world
Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe,
Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe,
We are a team of enthusiastic Solutions Engineers working from different offices and remotely across the globe. We support each other and we share our knowledge - within our own team but also across the global
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About Zscaler Zscaler (NASDAQ: ZS) accelerates digital transformation so that customers can be more agile, efficient, resilient, and secure. The Zscaler Zero Trust Exchange is the company’s cloud-native platform that protects thousands of customers from cyberattacks
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As the Financial Controller (Lead), youll play a pivotal role in financial management, ensuring compliance with regulations, and driving strategic analysis. Your decisions will impact the companys financial health, budgeting, and forecasting. Join the dynamic team
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As the HR Business Partner (HRBP) for the After Sales Function, you will play a pivotal role in supporting and enhancing our post-sales service operations. You will collaborate closely with managers and employees to drive HR
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Sr. FP&A role to work closely with the commercial side of the business | Global environment, WFH available Client Details This global biopharmaceutical company focuses on several key therapeutic areas and is known for its patient-centric
You will play a critical role in bridging the communication gap between Japan and the regional/global teams. Manage a small team. If you are looking to focus on management rather than a technical position this role
* The Account Manager will be driving the sales of simulation software to fit with customer needs, especially for manufacture/ machinery industry. * Most of the clients are in Aichi prefecture and Tokyo area. Client Details
