Manager, QARA GCC Markets

About the role

The Manager, QARA GCC Markets provides operational leadership for quality assurance and regulatory affairs across the Gulf Cooperation Council (GCC) region. This role ensures regulatory compliance, effective quality management system execution, and sustained market access for DePuy Synthes’ Orthopedics portfolio. You will partner closely with local, regional, and global stakeholders to support patient safety and business growth.

Key responsibilities

• Lead and manage Quality Assurance and Regulatory Affairs activities to support product registrations, renewals, variations, and lifecycle management across GCC markets.
• Ensure compliance with local and regional regulatory requirements, international standards, QMS expectations, and internal policies.
• Serve as the primary QARA point of contact for GCC markets, providing strategy, guidance, and execution support.
• Coordinate regulatory submissions, technical documentation, renewals, and responses to health authority inquiries.
• Partner with cross‑functional teams including Quality, Supply Chain, Commercial, Legal, and Global QARA to support business objectives and supply continuity.
• Monitor regulatory and quality requirement changes across GCC markets and assess potential impacts.
• Support and participate in regulatory inspections, quality audits, and health authority assessments.
• Contribute to continuous improvement initiatives to enhance QARA processes, efficiency, compliance, and inspection readiness.
• Engage proactively in regional policy initiatives critical to business strategy and growth.

Required profile

Required skills

• Regulatory affairs
• Quality assurance
• Product registration