Associate Dir, Qara Mx / N. Cluster
8283-Ees S.A De C.V. Legal Entity
Job Description
OverviewThe Associate Director, Quality Assurance & Regulatory Affairs (QARA) – Mexico / Northern Cluster provides strategic and operational leadership for quality assurance and regulatory affairs activities across Mexico and the Northern Cluster.
This role is accountable for ensuring regulatory compliance, effective quality management system execution, and sustained market access for DePuy Synthes' Orthopedics portfolio.
The position is a high‐impact leadership role with direct influence on product lifecycle decisions, health authority interactions, inspection readiness, and regional QARA excellence.Key ResponsibilitiesLead and coordinate Q&A activities for new, modified, and marketed medical devices across Mexico and the Northern Cluster.Develop and execute integrated quality and regulatory strategies to support product registrations, notifications, approvals, and long‐term market sustainability, including alignment with U.S. FDA and EU MDR pathways as applicable.Ensure co...