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 -
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
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
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Company Description At ServiceNow, our technology makes the world work for everyone, and our people make it possible. We move fast because the world can’t wait, and we innovate in ways no one else can for
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企業概要 Digitas is The Connected Marketing Agency of Publicis Groupe - committed to helping brands better connect with people through strategy, design and data excellence. Overview Digitas, The Connected Marketing Agency of Publicis Groupe, is seeking
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Company Description Wolt is a technology company that makes it incredibly easy to discover and get the best restaurants, grocery stores and other local shops delivered to your home or office. Since launching 7 years ago,
Company Description Wolt is a Helsinki-based technology company that provides an online platform for consumers, merchants and couriers. It connects people looking to order food and other goods with people interested in selling and delivering them.
