Product Registration Jobs

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.