Medical Devices Regulatory Specialist

About the Role

Motaded Consultancy's regulatory team is expanding to include medical device registration tasks with the Saudi Food and Drug Authority (SFDA). This role focuses on managing the entire lifecycle of Medical Device Marketing Authorization (MDMA) for their clients. It is primarily a regulatory position rather than a technical or biomedical maintenance function.

Key Responsibilities

• Classify medical devices and in vitro diagnostics (IVDs) according to SFDA's risk-based system (Classes A through D), following IMDRF principles.
• Prepare and submit comprehensive Technical File Assessment (TFA) dossiers through the SFDA GHAD portal, utilizing MDMA2 and the Saudi route.
• Assist clients with Authorized Representative (AR) requirements, including facilitating legalized AR agreements and setting up GHAD accounts.
• Compile complete technical files, including device descriptions, intended uses, design and manufacturing details, ISO 13485:2016 certificates and surveillance audits, IEC 60601 safety and EMC reports, sterilization and shelf-life documentation, and Arabic labeling or Instructions for Use (IFU) when necessary.
• Promptly respond (ideally within 48 hours) to any SFDA inquiries or deficiency notices to avoid processing delays.
• Oversee post-market responsibilities such as MDMA renewals (valid for up to 3 years), handling variations, and reporting adverse events and Field Safety Corrective Actions (FSCA) to the National Center for Medical Device Reporting (NCMDR).
• Provide strategic advice to clients on registration processes, leveraging existing CE marks or approvals from GHTF markets to expedite Saudi dossier submissions.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline.
• Working knowledge of SFDA medical device regulations, including MDMA2, the GHAD portal, and the MDS-REQ framework, along with device classification procedures.
• Familiarity with ISO 13485 standards, technical file and TFA structures, and international frameworks such as EU MDR and IMDRF is highly advantageous.
• Previous experience in medical device regulatory affairs within Saudi Arabia or the Gulf region is preferred.
• Excellent attention to detail with strong emphasis on documentation and adherence to Standard Operating Procedures (SOPs).
• Professional proficiency in English is required; knowledge of Arabic is a strong plus, especially for Arabic labeling and communication with the SFDA.
• Capability to work on-site in Riyadh as part of a multi-disciplinary team.