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
Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier,
Our globally known tech services client is hiring a Bilingual Python Software Engineer for their cloud project! Apply now for consideration, this is a full-time permanent job! [Client] A Global MNC /ICT Service Company based in Tokyo.
Intersoftkk Inc. is a global Information Technology and Services Company offering all sorts of web and mobile application design & development, Salesforce & SAP enterprise solutions. We are a leading Digital Transformation Service firm with a rich
Intersoftkk Inc. is a global Information Technology and Services Company offering all sorts of web and mobile application design & development, Salesforce & SAP enterprise solutions. We are a leading Digital Transformation Service firm with a rich
Your Job In the role of Director of Supply Planning, you will have key responsibilities critical to the organizations success. You will be responsible for overseeing the supply planning function, creating end to end supply chain
Your Job Product Engineer is responsible for all phases of the product development, from concept to pre-production, including the multi-disciplinary actions necessary to meet customers requirements. What You Will Do 1. Together with Engineering team, perform
Your Job This position has the responsibility to input Design Preference and Manufacturing POV in early phase of Product development to realize the best cost performance. Our Team CCS Division / Operation Strategy What You Will
Your Job The Group Product Manager preferred to be functioned both independently as well as in a team. Responsible for product portfolio P&L in key markets as wells as driving growth with new products / markets,
Your Job Optical Amplifier Development What You Will Do Optical engineer to design for optical telecommunication equipment, especially for optical amplifier, EDFA and Raman amplifiers. Responsible for whole product design of optical amplifier, such like to
Your Job The Business Development Manager will be able to function both independently and as a team player. Responsible for working with Global Account and Product Management teams to define a strategy for the Japan Automotive market.
As a DevOps engineer you are responsible for creating and managing Docker Images, Kubernetes for containerisation and automate processes of the platform. This role is an opportunity for you to use your expertise in CI/CD pipeline
To achieve stable operation and delivery of these services with minimal manual intervention, we actively embrace new technologies and automation. In this position, we are looking for someone who is highly motivated to improve the operation
Your Job As an Industrial Automation Business Development Manager, you will be responsible for driving the growth and success of Molex in the Japanese market. Working closely with Sales APN and Product Management, you will be
Your Job The Product Manager preferred to be functioned both independently as well as in a team. RResponsible for product development and its profitability.P&L in key markets as wells as driving growth with new products /
Your Job Molexs Commercial and Consumer Solutions (CCS) Division is seeking an entrepreneurial individual to be a critical member of our Product Management (PM) Group located in Yamato, Japan and a variety of other strategic locations
Your Job Ensure customer satisfaction by assessing the quality of products and taking ownership of communication between the plant and customer. What You Will Do 1. Make initial analysis of customer returned parts, including returns from
Your Job Japan Legal Manager What You Will Do Ø Team with Division Counsel and other members of the global legal department to seamlessly provide legal advice to the business Ø Prepare, review, and provide guidance on
Your Job The Raw Materials Category Sourcing Engineer plays a pivotal role in managing raw materials and components for connectors within the CCS Division. This position holds category sourcing responsibilities for production in Japan, overseeing both
Join an innovative biopharmaceutical company dedicated to pioneering advancements in healthcare. Our client is seeking a dynamic and experienced Cardiovascular Product Manager to lead our in developing and executing marketing strategies for their new cardiovascular product
