Mdsap Jobs

Experienced post-market quality professional needed to manage complaint investigations, generate KPI reporting, and support MDR/FAR vigilance activities for a major medical products 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.

Experienced regulatory/quality professional needed to maintain QMS activities, drive CAPA and change control, and support audit and regulatory documentation for a growing medical device company in New York State.