Description
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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory Product Submissions and RegistrationJob Category:
ProfessionalAll Job Posting Locations:
Jeddah, Makkah, Saudi ArabiaJob 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 our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and 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 at an appropriate time and 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, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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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