Associate Dir, QARA MX / N. Cluster

Job Description

Johnson & Johnson announced plans to separate our Orthopaedics business into DePuy Synthes. The Associate Director, QARA will lead quality assurance and regulatory affairs across Mexico and the Northern Cluster, ensuring compliance, market access and product lifecycle support.

Key Responsibilities

• Lead and coordinate QA and RA activities for new, modified and marketed devices across Mexico and the Northern Cluster.
• Develop and execute integrated quality and regulatory strategies for product registrations, notifications, approvals, and long‑term market sustainability, including alignment with U.S. FDA and EU MDR pathways.
• Ensure compliance with local regulatory requirements, international standards, and DePuy Synthes quality management system policies.
• Prepare, review, and oversee high‑quality regulatory submissions, technical documentation and registration files.
• Lead and support health auth...