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.

Your Role

• 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.

Your Profile

• Expert knowledge in medical device development and manufacturing.
• Strong background in regulatory approval processes.
• Specialized knowledge of FDA regulations and submission requirements.
• Fluent in English and German, enabling effective communication in international and regulatory contexts.

What you’ll love about working here?

• An environment in which you can constantly develop yourself. Our range of training programs are designed to help you discover a world of opportunities - be it through specialist training, mentoring or innovative projects.
• Work-life balance: Work flexibly - depending on the project assignment and agreement within the team, you have the opportunity to work flexibly in terms of location and flexitime at various locations.
• Diversity ensures inspiration and innovation in our company - work in a diverse and open team that relies on mutual support and exchange.

Not a 100% match? No need to worry! Capgemini Engineering supports you with a wide range of learning opportunities so that you can develop both professionally and personally.

WE LOOK FORWARD TO MEETING YOU

Do you have any questions about the job profile and/or requirements?
Please get in touch with your contact person in Recruiting.
Michel Haverkamp, Recruiter Capgemini Engineering Deutschland S.A.S. & Co. KG
michel.haverkamp@capgemini.com
Please fill in our online application form completely and attach your CV, work and school certificates as well as any other relevant documents.
We wish you every success for your application.