De Novo Jobs

Technical regulatory leader sought to author and drive FDA regulatory strategy and submissions for AI/ML-enabled SaMD at a fast‑moving digital health company.

ARK Diagnostics is hiring a Regulatory Affairs Specialist II to own international product registrations, support submissions (e.g., 510(k), De Novo, IVDR), and maintain regulatory compliance at its Fremont, CA facility.

ARK Diagnostics is hiring a Regulatory Affairs Specialist II to manage international device registrations, prepare regulatory submissions (including 510(k), De Novo, and IVDR technical documentation), and support lifecycle compliance for IVD and medical device products.

Nextern is looking for a Senior Systems Engineer to lead system architecture, risk management, and verification/validation for electro-mechanical medical device projects.

Lead large-scale, cross-functional product development programs at Intuitive to deliver next-generation minimally invasive surgical platforms from concept to commercial launch.