MEA QA/RA Specialist II - Regulatory Impact & Quality

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

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.