Manager QARA GCC Markets📣 إعلان

About the Role: Manager, QARA GCC Markets

Johnson & Johnson MedTech is seeking a Manager, Quality Assurance and Regulatory Affairs (QARA) for its GCC Markets. This full-time position will be based in Makkah, Saudi Arabia, with responsibilities covering Jeddah and Makkah. The role requires 5-10 years of experience in quality assurance and regulatory affairs within regulated industries.

Role Overview and Purpose

The Manager, QARA GCC Markets will provide operational leadership for quality assurance and regulatory affairs across the Gulf Cooperation Council (GCC) region. This role is critical for ensuring regulatory compliance, effective quality management system execution, and sustained market access for the DePuy Synthes Orthopedics portfolio. The position supports compliant product registrations, lifecycle management, and inspection readiness, while collaborating with various stakeholders to ensure patient safety and business growth.

Key Responsibilities

• Lead and manage Quality Assurance and Regulatory Affairs activities for product registrations, renewals, variations, and lifecycle management within GCC markets.
• Ensure adherence to local and regional regulatory requirements, international standards, quality management system expectations, and internal policies.
• Act as the primary QARA point of contact for GCC local markets, offering guidance and execution support for quality and regulatory strategies.
• Coordinate regulatory submissions, technical documentation, renewals, and responses to health authority inquiries.
• Collaborate with cross-functional teams including Quality, Supply Chain, Commercial, Legal, and Global QARA to achieve business objectives and ensure supply continuity.
• Monitor changes in regulatory and quality requirements across GCC markets and assess potential impacts on products, supply, and operations.
• 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 and help shape regional policy initiatives that are important for business strategy, continuity, and growth.

Required Qualifications and Experience

• Education: Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
• Experience: 6–8 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device, healthcare, or other regulated industries.
• Knowledge: Strong working knowledge of GCC regulatory requirements, health authority processes, and quality system principles.
• Skills: Experience managing product registrations and lifecycle activities across multiple markets; ability to interpret and apply regulatory and quality requirements; strong stakeholder management, communication, and collaboration skills; ability to manage multiple priorities in a complex, fast-paced, and matrixed environment.

Preferred Qualifications

• Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.
• Experience supporting emerging market regulatory and quality models.
• Familiarity with global regulatory frameworks and harmonization initiatives.
• Experience working in multinational or matrixed organizations.
• Exposure to regulatory inspections, quality audits, or health authority interactions.
• Demonstrated experience contributing to process improvement or regulatory/quality transformation initiatives.
• Regulatory Affairs or Quality certification (*, RAC or equivalent).

Work Environment and Language

This is a full-time position located in Makkah, Saudi Arabia, covering the GCC markets. Limited regional travel across GCC markets is expected. Fluency in English is required, and proficiency in Arabic is preferred.