Regulatory Affairs Lead – Medical Devices (EU MDR & SFDA)

Medicuras Trading llc fz; Dubai; Vor Ort; AED 180.000 - 320.000; Vollzeit

Zusammenfassung

Medicuras Trading llc fz in Dubai seeks an experienced Regulatory Affairs Specialist to lead the authoring, compilation, and maintenance of EU MDR technical files and manage SFDA MDMA applications. You will bridge international conformity with regional submission pathways to secure swift approvals and lifecycle compliance.

The role requires 3–6 years in regulatory affairs for medical devices/IVDs, strong English communication, and readiness to operate from Dubai. Arabic proficiency is a plus.

Qualifikationen

• Bachelor’s degree in Biomedical Engineering, Pharmacy, Life Sciences.
• 3 to 6 years of direct hands-on regulatory affairs experience in medical devices or IVDs.
• EU MDR proficiency with drafting and maintaining Technical Files/Design Dossiers.
• Strong working knowledge of SFDA regulations and GHAD portal.
• Solid knowledge of ISO 13485, ISO 14971, and IEC standards for medical devices.
• Excellent written and verbal technical English; Arabic is a strong advantage.
• Based in Dubai or able to join locally.

Aufgaben

• Prepare and submit regulatory dossiers (EU MDR/MDMA) and manage end-to-end SFDA submissions.
• Maintain submissions databases, tracking timelines, approvals, and commitments.
• Review labeling, IFU, and packaging for regulatory compliance.
• Stay updated on evolving regulatory guidelines and assess impact.
• Author, structure, and maintain Technical Documentation to EU MDR Annex II/III.
• Coordinate with clinical and engineering teams to integrate CER, PMS, PMCF data.
• Address RFIs and inquiries from Notified Bodies; liaise with authorities.
• Monitor SFDA regulatory updates to keep portfolio compliant.

Kenntnisse

Regulatory affairs

EU MDR proficiency

GSPR checklists

Technical documentation

Clinical Evaluation Reports

Ausbildung

Bachelor’s degree in Biomedical Engineering, Pharmacy, Life Sciences

Tools

SFDA GHAD portal

ISO 13485

ISO 14971

Jobbeschreibung

Medicuras Trading llc fz in Dubai seeks an experienced Regulatory Affairs Specialist to lead the authoring, compilation, and maintenance of EU MDR technical files and manage SFDA MDMA applications. You will bridge international conformity with regional submission pathways to secure swift approvals and lifecycle compliance.

The role requires 3–6 years in regulatory affairs for medical devices/IVDs, strong English communication, and readiness to operate from Dubai. Arabic proficiency is a plus.