ERD部門 - Regulatory Documentation Lead

Engineering Utsunomiya/ Nasu, Tochigi

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Description

Position at Capgemini Japan

Regulatory Documentation Lead  
  
 
Company Profile  
Capgemini Engineering combines, under one brand, a unique set of strengths from across the Capgemini Group: world-leading engineering and R&D and digital manufacturing expertise. With broad industry knowledge and cutting-edge technologies in digital and software, Capgemini Engineering supports the convergence of the physical and digital worlds. Combined with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 60,000 engineer and scientist team members in over 30 countries across sectors including aeronautics, automotive, railways, communications, energy, life sciences, semiconductors, software & internet, space & defense, and consumer products.  
 
Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of 360,000 team members in nearly 50 countries. With its strong 50-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering, and platforms. The Group reported in 2022 global revenues of €22 billion.  
 
  
Location  
Tochigi   
Remote work is not allowed  
  
 
The role  
Will be in charge of doing Regulatory documentation for the customer’s medical device. Will work directly with customers on the scope of the documentation and guide subordinate teams on the documentation and reviews.  
  
 
Responsibilities  
  • Experience in documentation preparation for medical device regulatory submissions 
  • Managing team and reviews 
  • Managing: Scheduling, Monitoring and Reporting 
  • Proactive approach and focused on Release and Delivery success 
  • Talk with Remote teams in various geographies 
  
Profile  
To fulfil the role, we are looking for talented candidates with the following profile:  
Mandatory  
  • Regulatory Documentation Lead with 7 years of experience in Medical Device Regulatory documentation 
  • English skill: Business level  
  • Japanese skill: Native/Business level 
  
  
Preferred  
  • Medical Device regulatory for Radiology products 
 
 

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For vendors:       

Please contact the following recruiters should you wish to apply candidates       

       

Capgemini ERD Talent Acquisition Team      

Francis Han (ERD TA Manager)       

Satoshi Akazawa (ERD TA)       

Ryu Tsuchiya (ERD Recruitment Coordinator)       

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キャップジェミニについて

キャップジェミニは、お客様のビジネストランスフォーメーションならびにテクノロジートランスフォーメーションのグローバルパートナーです。企業が“デジタル世界”と“持続可能な世界”への移行を加速できるようご支援し、組織と社会へのインパクトを目に見える形で生み出しています。当グループは、世界50か国以上、約34万人の使命感あふれる多様性に富んだチームメンバーから成る組織です。55年にわたり培ってきた豊富な実績を有し、幅広いビジネスニーズへの対応をテクノロジーの力で支援するパートナーとして、お客様から厚いご信頼をいただいています。AI、クラウド、データ領域で市場をけん引する能力を発揮し、各業界への深い専門知識とパートナーエコシステムを組み合わせ、戦略・設計からエンジニアリングまでを網羅する強みを活かして、エンドツーエンドのサービスやソリューションをご提供しています。2023年のグループ売上高は22.5億ユーロです。

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