Senior Consultant (m/w/d) Regulatory Affairs for Medical Devices, Software and AI

Brief description We support manufacturers in developing safe medical devices, efficiently meeting regulatory requirements, and bringing innovations to the international market as quickly as possible. We achieve this through consulting, digital tools, and seminars – and with a dedicated team that truly lives freedom, responsibility, and collaboration. Our working model? Remote, self-organized, holacratic – with true personal responsibility and plenty of creative freedom. This also means: no one waits for instructions here. We are looking for doers who take responsibility for their projects and independently lead consulting assignments to success. You can help shape your own professional development, particularly at the intersection of regulation, software, and AI. As a Senior Consultant (m/w/d), you don't just explain regulatory challenges, you solve them practically together with our clients. You develop viable strategies and support manufacturers in the international approval of innovative medical and software products. Your role in our team You develop regulatory approval strategies for medical devices and IVDs – for the EU, the USA, and gladly for international markets as well. You also support the approval of medical devices, including Software as a Medical Device (SaMD / SiMD), and have no fear of AI-based features. You translate regulatory requirements into concrete next steps –