Regulatory Affairs Specialist - SaMD AI for Heart Health

A leading AI medical technology firm based in Oxford is seeking a Regulatory Affairs Specialist to ensure compliance with EU and US regulations. This role involves preparing CE mark documentation, supporting FDA submissions, and managing post-market regulatory activities. Candidates should have 3-5 years of experience in the SaMD medical device industry and a strong understanding of regulatory requirements. Join us to shape the future of heart health and make a meaningful impact in cardiovascular diagnostics.