510(k) 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.

Experienced regulatory professional needed to drive U.S. regulatory strategy and submissions for complex robotic, electromechanical, and SaMD products at a leading surgical robotics company.

Experienced V&V engineer needed to lead verification and validation efforts for software-enabled medical devices, ensuring regulatory compliance and product quality across cross-functional teams.

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.