Medical devices specialist

Job Title: Medical Devices Regulatory Specialist — SFDA (MDMA)Company: Motaded Consultancy (شركة متعدد) — Riyadh | Full-time, On-siteAbout the RoleMotaded's regulatory consulting division is expanding to cover medical device registration with the Saudi Food and Drug Authority (SFDA). We are seeking a specialist to manage the full Medical Device Marketing Authorization (MDMA) lifecycle for clients — a regulatory role, not a technical/biomedical maintenance role.Key ResponsibilitiesClassify medical devices and IVDs under the SFDA risk-based system (Class A–D) per IMDRF principles.Prepare and submit complete Technical File Assessment (TFA) dossiers via the SFDA GHAD portal (MDMA2 / Saudi route).Support clients through the Authorized Representative (AR) requirement, including the legalized AR agreement process and GHAD account setup.Compile technical files: device description and intended use, design/manufacturing info, ISO 13485:2016 certificate and surveillance audit, IEC 60601 safety/EMC reports, sterilization and shelf-life data, and Arabic labeling/IFU where required.Respond to SFDA information requests and deficiencies promptly (ideally within 48 hours) to prevent delays.Manage post-market obligations: MDMA renewals (valid up to 3 years), variations, adverse-event and FSCA reporting to NCMDR.Advise clients on registration strategy and leverage existing CE / GHTF-market approvals to accelerate the Saudi dossier.QualificationsBachelor's degree in Biomedical Engineering, Pharmacy, Pharmaceutical/Life Sciences, or a related field.Knowledge of SFDA medical device regulations (MDMA2, GHAD portal, MDS-REQ framework) and device classification.Familiarity with ISO 13485, technical file / TFA structure, and international frameworks (EU MDR / IMDRF) — a strong advantage.Experience in medical device regulatory affairs in Saudi Arabia or the Gulf (preferred).High attention to detail, strong documentation and SOP discipline.Professional English; Arabic is a strong advantage (Arabic labeling and SFDA correspondence).Ability to work on-site in Riyadh within a multidisciplinary team.