QARA Specialist II Egypt

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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 postmarket 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 crossfunctionally with Commercial Supply Chain and other stakeholders to support compliant product commercialization.

Qualifications

Education

• Bachelors degree required (Life Sciences Engineering Pharmacy or related discipline preferred).

Experience and Skills

Required:

• Typically requires 24 years of relevant work experience in Quality Assurance Regulatory Affairs or a regulated healthcare/medical device environment for the countries in scope.

• Working knowledge of quality systems and regulatory processes in a regulated industry.

• Ability to follow defined procedures and contribute to process execution with attention to detail.

Preferred:

• Experience supporting regulatory activities within the scope countries and/or additional Middle East markets.

• Familiarity with medical device regulations and health authority requirements.

• Experience working in a matrixed global organization.

• Exposure to audits or inspections (internal or external).

• Strong organizational skills with the ability to manage multiple priorities.

• Effective written and verbal communication skills.

Other

• Languages: English required; Arabic preferred.

• Travel: Limited travel may be required.

• Certifications: Regulatory or Quality certifications (e.g. RAC ISO-related) preferred but not required.

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