QA/RA Specialist II Egypt & Rest of MEA

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Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Product Submissions and Registration

Job Category:
Professional

All Job Posting Locations:
Jeddah, Makkah, Saudi Arabia

Job Description:

DePuy Synthes is recruiting for a(n) QA/RA Specialist II Egypt & Rest of MEA, located in Riyadh, Saudi Arabia.

The QA/RA Specialist II Egypt & Rest of MEA supports the execution of Quality Assurance and Regulatory Affairs (QARA) activities across various MEA countries including but not limited to Egypt, Iraq, Libya, etc.

This role contributes to maintaining regulatory compliance, supporting product lifecycle activities, and ensuring alignment with local health authority requirements.

The position plays a meaningful role in enabling timely patient access to DePuy Synthes orthopedic solutions while supporting quality systems and continuous improvement across the region.

Key Responsibilities


* Support preparation, submission, and maintenance of regulatory documentation for the scope countries in alignment with local health authority requirements.



* Provide subject matter expertise in reference to scope countries for local regulatory and quality requirements



* Assist in the execution of Quality Management System (QMS) processes, including document control, change management, and records maintenance.



* Coordinate with regional and global QARA partners to support product registrations, renewals, and post‑market changes.



* Contribute to compliance activities related to audits, inspections, and internal quality reviews.



* Support monitoring of regulatory changes and help assess potential impact to existing and future products in the scope markets.



* Maintain accurate regulatory and quality records in designated systems to ensure inspection readiness.



* Collaborate cross‑functionally with Commercial, Supply Chain, and other stakeholders to support compliant product commercialization.

Qualifications

Education


* Bachelor's degree required (Life Sciences, Engineering, Pharmacy, or related discipline preferred).

Experience and Skills

Required:


* Typically requires 2-4 years of rel...