Regulatory Affairs Specialist – Medical Devices

About the role

We are seeking a Regulatory Affairs Specialist to manage registration dossiers for new and re‑registered medical devices, handle analytical submissions to NODCAR, and support the logistics team with required documentation.

Key responsibilities

• Prepare registration dossiers for all new and re‑registered products and submit variations of existing products.
• Prepare and submit analytical dossiers to NODCAR and follow up on submissions, supporting documents, and registration lead times.
• Support the logistics team with references, legalized certificates, and materials needed for analysis and release.
• Prepare analytical files for authorized labs, monitor analysis, and obtain release certificates for samples.
• Ensure confidentiality of registration files and complete all registration requirements for shipments at EDA.
• Obtain Ministry of Health import approvals, inspections, and releases.

Required profile

• Bachelor’s degree in Science, pharmacy or veterinary medicine.
• Knowledge of EDA regulatory affairs and hands‑on experience in medical device registration.
• Experience with sterile medical devices regulatory submissions, CAPA and NODCAR processes.
• Excellent command of English and Arabic.
• 1–3 years of relevant experience.

Required skills

• Medical device regulatory submissions
• Analytical dossier preparation for NODCAR
• CAPA process management