JOB DESCRIPTION

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

COMPANY DESCRIPTION

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2024 global revenues of €22.1 billion.

• Support the preparation and coordination of FDA submissions by assisting cross-functional teams in compiling, reviewing, and finalizing all required documentation and deliverables.
• Provide expert interpretation of FDA regulations and guidance documents to ensure alignment with current regulatory expectations and industry best practices.
• Contribute to the development and refinement of submission strategies, including timeline planning, content structuring, and communication with regulatory authorities.
• Conduct detailed reviews of technical documentation to ensure full compliance with FDA requirements, identify gaps or inconsistencies, and recommend corrective actions.