MEA QA/RA Specialist II — Regulatory & Quality

Brighter Signals; Jeddah; Vor Ort; SAR 180.000 - 240.000; Vollzeit

Zusammenfassung

Johnson & Johnson in Saudi Arabia seeks a QA/RA Specialist II to support regulatory affairs across MEA countries, including Egypt. You will assist in regulatory submissions, maintain QMS processes, and collaborate with regional partners to ensure timely registrations and inspections readiness.

The role requires 2–4 years in QA/RA within regulated healthcare or medical devices, with knowledge of local health authority requirements and strong documentation skills.

Qualifikationen

• 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.
• Familiarity with medical device regulations and health authority requirements.

Aufgaben

• 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.

Kenntnisse

Analytical Reasoning

Brand Research

Business Behavior

Design Thinking

Detail-Oriented

Execution Focus

Market Research

Package and Labeling Regulations

Product Licensing

Product Packaging Design

Project Management

Quality Assurance (QA)

Regulatory Affairs Management

Regulatory Compliance

Safety-Oriented

Ausbildung

Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or related discipline

Jobbeschreibung

Johnson & Johnson in Saudi Arabia seeks a QA/RA Specialist II to support regulatory affairs across MEA countries, including Egypt. You will assist in regulatory submissions, maintain QMS processes, and collaborate with regional partners to ensure timely registrations and inspections readiness.

The role requires 2–4 years in QA/RA within regulated healthcare or medical devices, with knowledge of local health authority requirements and strong documentation skills.