Medical devices specialist📣 إعلان

About Motaded Consultancy

Motaded Consultancy is expanding its regulatory consulting division to encompass medical device registration with the Saudi Food and Drug Authority (SFDA). Based in Riyadh, Saudi Arabia, the firm provides specialized guidance to clients navigating complex regulatory landscapes within the medical devices sector.

The Medical Devices Specialist Role

We are seeking a Medical Devices Specialist to join our team in a full-time capacity. This role is focused on managing the complete Medical Device Marketing Authorization (MDMA) lifecycle for our clients. It is a dedicated regulatory position, distinct from technical or biomedical maintenance functions.

Key Responsibilities

• Classify medical devices and In Vitro Diagnostics (IVDs) according to the SFDA risk-based system (Class A–D), adhering to IMDRF principles.
• Prepare and submit comprehensive Technical File Assessment (TFA) dossiers via the SFDA GHAD portal, specifically for MDMA2 / Saudi route applications.
• Support clients in fulfilling the Authorized Representative (AR) requirement, including the legalized AR agreement process and GHAD account setup.
• Compile technical files, which include device description and intended use, design and manufacturing information, ISO 13485:2016 certificate and surveillance audit reports, IEC 60601 safety and EMC reports, sterilization and shelf-life data, and Arabic labeling/Instructions For Use (IFU) where mandated.
• Respond to SFDA information requests and address deficiencies promptly, ideally within 48 hours, to prevent application delays.
• Manage post-market obligations, including MDMA renewals (valid for up to 3 years), variations, and adverse-event and Field Safety Corrective Action (FSCA) reporting to the National Center for Medical Device Reporting (NCMDR).
• Advise clients on optimal registration strategies and leverage existing CE / GHTF-market approvals to expedite the Saudi dossier submission process.

Experience and Qualifications

Candidates should possess 0-1 years of relevant experience in medical device regulatory affairs or a related field. A strong understanding of SFDA regulations and IMDRF principles is essential for this role.

Work Environment

This is a full-time position based in Riyadh, Saudi Arabia. The role requires on-site presence to effectively manage client engagements and regulatory submissions within a professional consulting environment.

Application Information

Interested candidates are invited to submit their application for this role. Further details regarding the application process will be provided upon initial contact.