QA/RA Specialist II Egypt & Rest of MEA

Johnson & Johnson Innovative Medicine; Jeddah; On-site; SAR 210,000 - 320,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Jeddah seeks a QA/RA Specialist II to drive regulatory submissions and maintain compliance across MEA markets. The role focuses on quality systems, document controls, and cross‑functional collaboration to ensure timely patient access to orthopedic solutions.

Qualified candidates bring 2–4 years in QA/Regulatory affairs, with a life sciences background and strong attention to detail. English required; Arabic preferred. Occasional travel may be required.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or related field.
• 2–4 years in QA, Regulatory Affairs, or regulated medical device environment.

Responsibilities

• Prepare, submit, and maintain regulatory docs for MEA scope.
• Provide SME on local regulatory and quality requirements.
• Support QMS processes: document control, change management, records.
• Coordinate with regional/global QARA for registrations and renewals.
• Assist audits, inspections, and internal quality reviews.
• Monitor regulatory changes and assess impacts on products.
• Maintain regulatory/quality records for inspection readiness.
• Collaborate with Commercial, Supply Chain, and other stakeholders.

Skills

English proficiency

Arabic preferred

Regulatory affairs

Quality systems

Documentation control

Communication skills

Education

Bachelor's degree

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson announced plans to separate ourOrthopaedicsbusiness toestablisha standaloneorthopaedicscompany, operating as DePuySynthes. The process of the planned separation isanticipatedto be completed within 18 to24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may berequired, regulatory approvals and other customary conditions and approvals. Should you accept this position, it isanticipatedthat, following conclusion of the transaction, you would be an employee of DePuySynthesand your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes atan appropriate timeand subject to any necessary consultation processes.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal,stateor local law. We actively seek qualified candidates who areprotectedveterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnsoniscommitted to providing an interview process that isinclusiveofour applicants’ needs. If you are an individual with a disability and would like to requestan accommodation, external applicants please contact us viahttps://www.jnj.com/contact-us/careers ;!!KynuNviudA!ACr8Oy9sWWIT-vFDoGWUroUuWcZaHwMCVbD5NIwcbAjqP1HQs7MTFE9rTTp3GhIZ94w8NPBi-PDDOBEmqVBL$), internal employees contactAskGSto be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Execution Focus, Market Research, Package and Labeling Regulations, Process Oriented, Product Licensing, Product Packaging Design, Project Management, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Safety-Oriented