About this role
Regulatory Affairs Engineering Lead, AI/ML at Neko Health. Location: Stockholm or Birmingham or Germany or London or Manchester. Role: developing strategy, preparing submissions, supporting surveillance Requirements: 3+ years regulatory/quality experience for medical devices, working knowledge of EU MDR, IEC 62304/82304‑1 and FDA 21 CFR Part 820 or UK MDR; experience with AI/ML regulatory requirements; degree in engineering or relevant science preferred. Category: Legal and Compliance Seniority: Mid Level Commitment: Full Time Workplace: Hybrid Languages: English