Regulatory Affairs Expert Medical Device Approval (m/w/d) – Focus on the USA

PAJUNK® is a family-run company with around 700 employees worldwide and is headquartered in Geisingen, southern Germany. We develop need-oriented medical devices with the aim that medical professionals worldwide can concentrate on what really matters: the patients. We combine the strength of a market leader with the agility of a start-up. They benefit from a safe workplace through innovative products in a crisis-proof industry and an international environment. In addition, you can expect short decision-making and an appreciation of each other, so that real teamwork is possible. Support our team as Regulatory Affairs Expert Medical Device Approval (m/w/d) from 01.07.2025.

They take responsibility for the approval of our new and existing products in the USA so that they are introduced in a regular and timely manner. This includes the strategic planning and coordination of approvals as well as the creation and submission of approval files via eStar (e.g. 510(k)). By maintaining approval and product databases (FURLS) and supporting our US agent as well as the Official Correspondent, make sure that all registration data is always up-to-date and legally compliant. You can also support UDI management (GUDID) to ensure complete product identification and product identification. In addition, monitor regulatory developments and ensure that legal requirements are implemented in cooperation with the specialist departments.

Ideally studies in engineering, natural science, human medicine, medical technology or life science First professional experience in Regulatory Affairs/accreditation is advantageous Proactive operation with a view to efficient solutions Communication skills and fun at working with open-minded colleagues from your team and adjacent departments Very good knowledge of German and English in word and writing

Varied tasks and the possibility to help shape future-relevant projects A modern working environment and openness for new technologies An attractive salary package (Christmas and holiday allowance, voluntary service allowance, distance-based fare grant) An extensive health and sports offer (ergonomic jobs, business sports, Hansefit, health days, company doctor, free vaccination) Seasonal and enjoyable food, freshly prepared by our kitchen team JOBV1_EN