Regulatory Affairs Consultant | Berater (m/w/d) Regulatory Affairs

Job Summary

This role at VDE involves shaping the future of medical software and AI by providing expert guidance on regulatory matters for the approval of medical software and AI systems. The consultant will take responsibility for planning, steering, and implementing client and partner projects, acting as a key expert and contact person for medical software and Regulatory Affairs. This includes building a professional network, sharing knowledge at events, and through publications. The ideal candidate will have a university degree in a relevant field such as medical technology, electrical engineering, computer science, or natural sciences, coupled with strong knowledge in Regulatory Affairs for active medical devices, particularly medical software and AI. The position requires expertise in quality management, technical documentation, conformity assessment, clinical evaluation, and post-market surveillance. Strong communication, client orientation, and problem-solving skills are essential, along with fluent German and English.