Regulatory Affairs Executive

Medicuras Trading llc fz; Dubai; On-site; AED 180,000 - 320,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory affairs

EU MDR proficiency

GSPR checklists

Technical documentation

Clinical Evaluation Reports

Education

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

Tools

SFDA GHAD portal

ISO 13485

ISO 14971

Job description

• Prepare and submit regulatory dossiers (e.g., CTD, eCTD) to health authorities, ensuring accuracy and compliance with global regulations.
• Manage and maintain regulatory submissions databases, tracking timelines, approvals, and commitments for all projects.
• Conduct thorough reviews of product labeling, advertising, and promotional materials to ensure regulatory compliance and accuracy.
• Stay abreast of evolving regulatory landscapes, including new guidelines, directives, and legislation, and proactively assess their impact.

Desired Candidate Profile

We are looking for an experienced Regulatory Affairs Specialist to join our team in Dubai. In this role, you will lead the authoring, compilation, and maintenance of EU MDR (2017/745) technical files and manage end-to-end medical device market authorization (MDMA) applications under the Saudi Food and Drug Authority (SFDA).You will bridge international technical conformity with regional submission pathways, ensuring swift approvals and sustained lifecycle compliance.

Key Responsibilities

• Author, structure, and maintain Technical Documentation in full alignment with EU MDR (2017/745) Annex II and III.
• Synthesize technical inputs to build core dossier sections: Device Description, General Safety and Performance Requirements (GSPR) checklists, Verification & Validation reports, and Risk Management Files (ISO 14971).
• Coordinate closely with clinical and engineering teams to integrate Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) plans, and Post-Market Clinical Follow-Up (PMCF) data.
• Actively address and resolve technical deficiencies, Request for Information (RFI) notices, and inquiries raised by Notified Bodies.

SFDA Submissions & Regional Market Access

• Prepare and submit Medical Device Marketing Authorization (MDMA) dossiers via the SFDA GHAD portal per MDS-REQ1.
• Determine device risk classification, submission pathways, and bundling strategies in accordance with MDS-G008 and MDS-G028.
• Ensure labeling, Instructions for Use (IFU), and packaging artwork comply with Saudi standards (MDS-G10).
• Support Authorized Representative (MDAR) requirements and liaise with distributors and regulatory bodies to manage application cycles.
• Monitor SFDA regulatory updates and circulars to keep the product portfolio fully compliant.

Quality & Lifecycle Management

• Maintain regulatory documentation aligned with ISO 13485 standards and internal Quality Management System (QMS) requirements.
• Support vigilance activities, including adverse incident reporting and Field Safety Corrective Actions / Field Safety Notices (FSNs).
• Assess engineering change orders (ECOs) and product modifications for their regulatory impact across target markets.

Candidate Profile & Requirements

• Education: Bachelor’s degree in Biomedical Engineering, Pharmacy, Life Sciences, or a related discipline.
• Experience: 3 to 6 years of direct hands-on regulatory affairs experience in medical devices or IVDs.
• EU MDR Proficiency: Proven track record of drafting and maintaining Technical Files/Design Dossiers under Regulation (EU) 2017/745.
• SFDA Expertise: Strong working knowledge of SFDA regulations, classification rules, guidance documents, and the GHAD portal.
• Standards & Compliance: Solid knowledge of ISO 13485, ISO 14971, and IEC standards relevant to medical devices.
• Communication Skills: Excellent written and verbal technical English communication skills; professional Arabic language proficiency is a strong advantage.
• Availability: Based in Dubai or able to join locally.