Functional/Technical Knowledge, Skills and Abilities Required: Strong knowledge of U.S. and international post-market, clinical evaluation, clinical investigation, vigilance, and Good Clinical Practice requirements, including applicable FDA regulations, ISO 13485, ISO 14155, and EU MDR. Leads the integrated Post Market Quality Assurance and Clinical Affairs functions, ensuring a compliant, effective QMS; timely identification and management of post-market signals; and development of clinical evidence supporting product safety, performance, and lifecycle decisions.