وظيفة أخصائي أجهزة طبية لدى شركة متعدد في الرياض

Job Title: Medical Devices Regulatory Specialist - SFDA (MDMA)

Company: Motaded Consultancy (شركة متعدد) - Riyadh | Full-time, On-site

About the Role

Motaded'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 Responsibilities

1. Classify medical devices and IVDs under the SFDA risk-based system (Class A-D) per IMDRF principles.
2. Prepare and submit complete Technical File Assessment (TFA) dossiers via the SFDA GHAD portal (MDMA2 / Saudi route).
3. Support clients through the Authorized Representative (AR) requirement, including the legalized AR agreement process and GHAD account setup.
4. 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.
5. Respond to SFDA information requests and deficiencies promptly (ideally within 48 hours) to prevent delays.
6. Manage post-market obligations: MDMA renewals (valid up to 3 years), variations, adverse-event and FSCA reporting to NCMDR.
7. Advise clients on registration strategy and leverage existing CE / GHTF-market approvals to accelerate the Saudi dossier.

Qualifications

1. Bachelor's degree in Biomedical Engineering, Pharmacy, Pharmaceutical/Life Sciences, or a related field.
2. Knowledge of SFDA medical device regulations (MDMA2, GHAD portal, MDS-REQ framework) and device classification.
3. Familiarity with ISO 13485, technical file / TFA structure, and international frameworks (EU MDR / IMDRF) - a strong advantage.
4. Experience in medical device regulatory affairs in Saudi Arabia or the Gulf (preferred).
5. High attention to detail, strong documentation and SOP discipline.
6. Professional English; Arabic is a strong advantage (Arabic labeling and SFDA correspondence).
7. Ability to work on-site in Riyadh within a multidisciplinary team.