Work Flexibility: Hybrid or Onsite Key Areas of Responsibility: Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Participates in advocacy activities of a more advanced technical and/or tactical or
Work Flexibility: Hybrid or Onsite 【Main Responsibilities】 ISO 13485およびQMS省令に基づき、品質マネジメントシステム（QMS）の構築・維持・継続的改善をリードし、各部門と連携して実効性のある運用を推進する 品質文書の管理体制を整備し、SOPの作成・改訂および教育を通じて、適切な文書運用と現場への定着を促進する グローバルの手順や要求事項を日本のQMSへ適切に展開し、国内規制との整合を確保しながら導入・運用を支援する 内部監査の計画策定・実施および是正措置のフォローアップを通じて、QMSの運用状況を評価し、改善機会を特定する マネジメントレビューに向けた品質指標および運用実績を取りまとめ、経営層への報告および改善活動の推進を支援する NC/CAPAプロセスの運用を推進し、不適合・逸脱に対する原因分析、是正処置の立案と実行および有効性確認、予防処置の立案と実行および有効性確認を関連部門と連携して行う 購買管理プロセスにおいて供給者の評価・再評価を実施し、要件を満たすサプライヤーの管理および管理体制の維持・強化を行う 第三者認証機関、規制当局（東京都庁・PMDA）およびCorporateによる監査・調査に対応し、準備から指摘事項への改善対応まで一貫してリードする 【Job Experience/knowledge/Skills/Competency】 ・医療機器QMSにおける業務経験5年以上 ・海外との業務遂行経験（必須ではない） ・医薬品医療機器等法及び関連法規制、QMS省令、ISO13485の正しい理解 ・ISO13485:2016の内部監査員資格（必須ではない） ・問題解決能力、論理的思考力 ・利害関係者との円滑なコミュニケーション力 ・日本語、英語（主にメール、必要時会議）Travel Percentage: None...
As a global leader in cybersecurity, CrowdStrike protects the people, processes and technologies that drive modern organizations. Since 2011, our mission hasn’t changed — we’re here to stop breaches, and we’ve redefined modern security with the
AWS is seeking a Principal Customer Success Specialist - Gen AI to transform how organizations plan, execute, and operate their businesses through adoption of Amazon Quick and AWSs generative AI platform. This is a senior individual contributor
MAIN REPONSIBILITIES / DUTIES JOB POSITION PURPOSE The MAS role family comprises a variety of medical scientific specialties, such as BU Medical and field based Medical. Be the Pfizer Japan medical scientific point of contact for
MAIN REPONSIBILITIES / DUTIES JOB POSITION PURPOSE The MAS role family comprises a variety of medical scientific specialties, such as BU Medical and field based Medical. Be the Pfizer Japan medical scientific point of contact for
Date Posted:2026-06-19 Country: Japan Location: Japan Otis Headquarters: Tokyo Sumitomo Twin Building East 13F, 2-27-1 Shinkawa, Chuo-ku, Tokyo, 104-0033 JAPAN Responsible for leading Japan FP&A execution across month-end closing, forecasting, reporting, and planning cycles, ensuring high-quality
Job Description As a Channel Digital Marketing Specialist, you will play a key role in driving profitable digital growth within the Japan & Australia market. You will be at the forefront of developing and executing optimized, channel-specific
Company Description インフォーマの一部門であるインフォーマ マーケッツは、業界が取引、革新、成長を行うためのグローバルプラットフォームを創造しています。私たちは、十数の専門市場において、450以上の大規模なブランドイベントおよび取引主導型イベントを開催しています。これらは通常、業界が集結し、人々がビジネスを行うために集まる、見逃せないライブおよびオンデマンドのB2Bイベントです。 また、データやデジタルコンテンツ、さらには企業が自社のビジネスや製品を紹介し、バイヤーが調査を行い、価値あるリードを生み出す年間を通じたオンラインプラットフォームも提供しています。 Informa Markets, a division within Informa, creates global platforms for industries to trade, innovate and grow. We organise over 450 large-scale branded and transaction-led events in over a dozen specialist markets.
Appealing Points: Lead Enterprise GCP IAM Strategy – Design and implement secure, scalable IAM frameworks across Google Cloud using least-privilege principles, organization policies, and identity governance. Build Secure Cloud-Native Solutions – Develop automation and cloud-native applications using
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
Company Description It all started when engineer Fred Luddy wrote code that automated a tedious task for his coworker, Phyllis. She cried tears of joy. That moment inspired Fred to build a company that could do
Company Description Wise is a global technology company, building the best way to move and manage the world’s money. Min fees. Max ease. Full speed. Whether people and businesses are sending money to another country, spending
Company Description It all started when engineer Fred Luddy wrote code that automated a tedious task for his coworker, Phyllis. She cried tears of joy. That moment inspired Fred to build a company that could do
The European Institute of Policy Research and Human Rights is a renowned academic institution offering advanced online programs dedicated to developing future leaders in policy research, human rights, and allied disciplines. Our mission is to provide
Appealing Points: Lead Enterprise GCP Cloud Programmes – Own end-to-end delivery of large-scale Google Cloud initiatives, managing technical strategy, execution, and successful go-live across multiple workstreams. Drive Cross-Functional Technical Leadership – Lead cloud engineers, IAM specialists, GKE administrators, and