وصف الوظيفة
Role Overview
QA/RA Specialist II Egypt & Rest of MEA at Johnson & Johnson (DePuy Synthes), located in Riyadh, Saudi Arabia.
Company Overview
DePuy Synthes is the orthopedics business of Johnson & Johnson. Johnson & Johnson is guided by its Credo and is committed to building a world where complex diseases are prevented, treated, and cured through expertise in Innovative Medicine and MedTech. The company provides an inclusive work environment that respects diversity and dignity of employees and recognizes their merit.
Role Purpose
The QA/RA Specialist II Egypt & Rest of MEA supports the execution of Quality Assurance and Regulatory Affairs activities across various MEA countries including but not limited to Egypt, Iraq, and Libya. This role maintains regulatory compliance, supports product lifecycle activities, ensures alignment with local health authority requirements, and enables timely patient access to DePuy Synthes orthopedic solutions while supporting quality systems and continuous improvement across the region.
Key Responsibilities
Regulatory Documentation and Submissions
- Support preparation, submission, and maintenance of regulatory documentation for scope countries in alignment with local health authority requirements.
- Coordinate with regional and global QARA partners to support product registrations, renewals, and post-market changes.
- Support monitoring of regulatory changes and help assess potential impact to existing and future products in scope markets.
Quality Management and Compliance
- Assist in the execution of Quality Management System (QMS) processes, including document control, change management, and records maintenance.
- Contribute to compliance activities related to audits, inspections, and internal quality reviews.
- Maintain accurate regulatory and quality records in designated systems to ensure inspection readiness.
Subject Matter Expertise and Stakeholder Collaboration
- Provide subject matter expertise in reference to scope countries for local regulatory and quality requirements.
- Collaborate cross-functionally with Commercial, Supply Chain, and other stakeholders to support compliant product commercialization.
Qualifications & Experience
- Bachelor's degree required in Life Sciences, Engineering, Pharmacy, or related discipline.
- 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.
- Experience supporting regulatory activities within scope countries and/or additional Middle East markets preferred.
- Exposure to audits or inspections (internal or external) preferred.
Skills & Competencies
- 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.
- Familiarity with medical device regulations and health authority requirements preferred.
- Strong organizational skills with the ability to manage multiple priorities.
- Effective written and verbal communication skills.
- Analytical reasoning, design thinking, detail-oriented mindset.
- Experience with Quality Assurance (QA), Regulatory Affairs Management, and Regulatory Compliance.
- Proficiency in proof reading, process orientation, and safety-oriented approach.
Additional Information
- 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.
- Employment Structure: Johnson & Johnson has announced plans to separate its Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, regulatory approvals, and other customary conditions. 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.
- Johnson & Johnson is an Equal Opportunity Employer and is committed to providing an inclusive interview process accommodating applicants' needs.