Quality & Regulatory Affairs Specialist

About the role

The Quality & Regulatory Affairs (QRA) Specialist supports regulatory and quality activities for PurposeBD’s medical devices across Qatar and other MENA markets. The role ensures that product registrations, imports, distribution, and post‑market processes comply with local regulations and company standards.

Key responsibilities

• Prepare and submit regulatory dossiers for new product registrations, renewals, variations, and lifecycle maintenance.
• Track submission timelines, follow up with local authorities and distributors, and ensure timely approvals.
• Maintain regulatory documentation and records in the company’s systems.
• Review promotional and advertising materials for regulatory compliance.
• Act as the primary regulatory contact for Qatar, liaising with national authorities and third‑party service providers.
• Provide regulatory input to commercial and supply‑chain teams for product launch readiness.
• Monitor regulatory updates, share relevant changes, and support implementation of new requirements.
• Support the local Quality Management System (QMS), documentation control, training records, and audit readiness.
• Assist with complaint handling, vigilance reporting, and coordination of field safety corrective actions.

Required profile

• Experience in regulatory affairs and quality assurance within the medical device or health‑technology sector.
• Familiarity with Qatar and MENA regulatory frameworks and product registration processes.
• Ability to manage documentation, track timelines, and coordinate with internal and external stakeholders.
• Proactive approach to identifying and escalating regulatory risks or delays.

Required skills

What we offer

• Opportunity to work with a leading global medical technology company.
• Collaborative environment across MENA regions.
• Exposure to a broad portfolio of innovative health products.