Regulatory Specialist

A Regulatory Affairs Specialist at Globus Medical assists in drafting, submitting, and gaining clearance for 510(k) and IDE/PMA submissions to the FDA for class II and III medical devices. The role involves developing regulatory submissions, reviewing clinical study data, determining regulatory pathways for new products, and ensuring compliance with FDA regulations and company policies. This position requires collaboration with product development, clinical affairs, and other functional teams to support the registration of orthopedic medical devices.