Senior FDA Expert (f/m/d)

<p>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&amp;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. </p> <p><strong>Your Role</strong></p> <ul><li>Support the preparation and coordination of FDA submissions by assisting cross-functional teams in compiling, reviewing, and finalizing all required documentation and deliverables.</li><li>Provide expert interpretation of FDA regulations and guidance documents to ensure alignment with current regulatory expectations and industry best practices.</li><li>Contribute to the development and refinement of submission strategies, including timeline planning, content structuring, and communication with regulatory authorities.</li><li>Conduct detailed reviews of technical documentation to ensure full compliance with FDA requirements, identify gaps or inconsistencies, and recommend corrective actions.</li></ul> <p><strong>Your Profile</strong></p> <ul><li>Expert knowledge in medical device development and manufacturing.</li><li>Strong background in regulatory approval processes.</li><li>Specialized knowledge of FDA regulations and submission requirements.</li><li>Fluent in English and German, enabling effective communication in international and regulatory contexts.</li> </ul> <p><strong>What you’ll love about working here?</strong></p> <ul><li>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.</li><li>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. </li><li>Diversity ensures inspiration and innovation in our company - work in a diverse and open team that relies on mutual support and exchange.</li></ul> <p><strong>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.</strong></p> <p><strong>WE LOOK FORWARD TO MEETING YOU</strong></p> <p>Do you have any questions about the job profile and/or requirements?<br/> Please get in touch with your contact person in Recruiting.<br/><strong>Michel Haverkamp, Recruiter </strong><strong>Capgemini </strong><strong>Engineering Deutschland S.A.S. &amp; Co. KG</strong><br/>michel.haverkamp@capgemini.com<br/>Please fill in our <strong>online application form</strong> completely and attach your CV, work and school certificates as well as any other relevant documents.<br/>We wish you every success for your application.</p> <p></p>