Manager, QARA GCC Markets
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Key skills for this role
About the Role
Johnson & Johnson MedTech is seeking a Manager for Quality Assurance and Regulatory Affairs (QARA) for the GCC markets, based in Riyadh. The role leads regulatory compliance, product registrations, and quality management for the DePuy Synthes Orthopedics portfolio.
Key Skills for This Role
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, applicable international standards, quality management system expectations, and internal policies.
- Serve as the primary QARA point of contact for GCC local markets, providing quality and regulatory 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 to products, supply, and operations.
- Support and participate in regulatory inspections, quality audits, and health authority assessments as required.
- Contribute to continuous improvement initiatives to enhance QARA processes, efficiency, compliance, and inspection readiness.
Requirements
- Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline
- 6–8 years of progressive experience in Quality Assurance and/or Regulatory Affairs within medical device, healthcare, or other regulated industries
- Strong working knowledge of GCC regulatory requirements, health authority processes, and quality system principles
- Experience managing product registrations and lifecycle activities across multiple markets
- Strong stakeholder management, communication, and collaboration skills
- Advanced degree or professional certification in Regulatory Affairs, Quality, or related field preferred
- Experience supporting emerging market regulatory and quality models preferred
- Regulatory Affairs or Quality certification (e.g., RAC or equivalent) preferred
Full Job Posting
Job Overview
- The Manager, QARA GCC Markets provides operational leadership for quality assurance and regulatory affairs across the Gulf Cooperation Council (GCC).
- This role is responsible for ensuring regulatory compliance, effective quality management system execution, and sustained market access for DePuy Synthes’ Orthopedics portfolio.
- This position plays a critical role in enabling compliant product registrations, lifecycle management, and inspection readiness while partnering closely with local, regional, and global stakeholders.
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, applicable international standards, quality management system expectations, and internal policies.
- Serve as the primary QARA point of contact for GCC local markets, providing quality and regulatory 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 to products, supply, and operations.
- Support and participate in regulatory inspections, quality audits, and health authority assessments as required.
- Contribute to continuous improvement initiatives to enhance QARA processes, efficiency, compliance, and inspection readiness.
- Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.
Qualifications
- Required: Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
- Preferred: Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.
- 6–8 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device, healthcare, or other regulated industries.
- Strong working knowledge of GCC regulatory requirements, health authority processes, and quality system principles.
- Experience managing product registrations and lifecycle activities across multiple markets.
- Ability to interpret and apply regulatory and quality requirements to support business and product decisions.
- Strong stakeholder management, communication, and collaboration skills.
- Ability to manage multiple priorities in a complex, fast‑paced, and matrixed environment.
- Preferred: Experience supporting emerging market regulatory and quality models.
- Preferred: Familiarity with global regulatory frameworks and harmonization initiatives.
- Preferred: Experience working in multinational or matrixed organizations.
- Preferred: Exposure to regulatory inspections, quality audits, or health authority interactions.
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