Ivdr 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 seeking an experienced Senior Clinical Affairs Specialist to lead clinical validation studies, specimen acquisition, and regulatory documentation for IVD assays at the 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.