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QA/RA Specialist II - Egypt & Rest of MEA

jj · Jeddah

جديد
Mid 🇬🇧 English
Quality Assurance Regulatory Affairs Quality Management System (QMS) Document control Change management

وصف الوظيفة

About the role

DePuy Synthes is recruiting a QA/RA Specialist II for Egypt and the rest of the Middle East and North Africa (MEA), based in Riyadh, Saudi Arabia. The role supports Quality Assurance and Regulatory Affairs (QARA) activities across MEA countries such as Egypt, Iraq and Libya, helping maintain regulatory compliance, support product lifecycle activities and align with local health authority requirements so patients can access orthopedic solutions in a timely way.

Key responsibilities

  • Support preparation, submission and maintenance of regulatory documentation in line with local health authority requirements.
  • Provide subject matter expertise on regulatory and quality requirements for the scope countries.
  • Assist with Quality Management System (QMS) processes, including document control, change management and records maintenance.
  • Coordinate with regional and global QARA partners on product registrations, renewals and post-market changes.
  • Contribute to audit, inspection and internal quality review compliance activities.
  • Monitor regulatory changes and assess their impact on current and future products.
  • Maintain accurate regulatory and quality records in designated systems for inspection readiness.
  • Work with Commercial, Supply Chain and other stakeholders to support compliant product commercialization.

Required profile

  • Bachelor's degree required; Life Sciences, Engineering, Pharmacy or a related discipline preferred.
  • Typically 2-4 years of relevant experience in Quality Assurance, Regulatory Affairs or a regulated healthcare/medical device environment for the scope countries.
  • English required; Arabic preferred.
  • Limited travel may be required.
  • Regulatory or quality certifications (e.g. RAC, ISO-related) preferred but not required.

Required skills

  • Working knowledge of quality systems and regulatory processes in a regulated industry.
  • Ability to follow defined procedures with attention to detail.
  • Preferred: experience supporting regulatory activities in the scope countries or other Middle East markets, familiarity with medical device regulations, exposure to audits or inspections, and experience in a matrixed global organization.
  • Strong organizational skills, effective written and verbal communication, and analytical reasoning.

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