Regulatory Affairs Engineering Lead, AI/ML

As the RA Engineering Lead for AI/ML Software, you will define and maintain Neko's regulatory strategy for AI- and ML-powered medical software across EU MDR, FDA, and UK MDR frameworks. This hands-on leadership role involves integrating compliance obligations like IEC 62304 and the EU AI Act directly into software development workflows while collaborating with engineering, clinical, and quality teams. You will prepare regulatory submissions, manage interactions with notified bodies, and design training to embed regulatory thinking into the organization's operations.