[Remote] Senior Technical Project Manager, SaMD at Oura

Candidates must have over 5 years of experience in a regulated environment under a medical device Quality Management System (21 CFR 820 or ISO 13485:2016) as a project manager. A degree in Biomedical/Computer Science or a related technical or scientific discipline is required. Demonstrated ability to assess and provide technical guidance for software as a medical device (SaMD), grasp holistic architecture across different contexts, and possess strong organizational, prioritization, and execution skills are essential. Detail orientation, strong leadership, excellent interpersonal, collaboration, and communication skills, along with an understanding of regulatory inspections and interactions with regulatory authorities, are also necessary.