Teams at Enovis

Lead global regulatory strategies and submissions for orthopedic medical devices and SaMD across US, EU and Australia. Manage pre-submissions, technical documentation (510(k), technical files), postmarket surveillance, CAPAs, recalls, and regulatory impact assessments. Serve as RA subject-matter expert on cross-functional teams, liaise with regulators (FDA, Notified Bodies, TGA), and ensure compliance with relevant standards and company QMS.