Regulatory Affairs Specialist
Core
Ensure timely product registrations and maintain regulatory compliance for medical devices across the MENA region, with a primary focus on Saudi Arabia.
Role type
Regulatory Affairs Specialist (Medical Devices)
Builds
Market access and product registrations for medical devices
Domain
Medical Devices / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device regulations knowledge, regulatory submission management, compliance management, ISO 13485 knowledge, Good Distribution Practice (GDP) knowledge, post-market surveillance knowledge, stakeholder relationship management, risk mitigation
Preferred skills
Tender submission support, import permit activities
Technologies
Microsoft Office
Responsibilities
Manage regulatory submissions and renewals, maintain compliance with local regulations and quality standards, build relationships with regulatory authorities, provide regulatory guidance to support business objectives, identify and mitigate regulatory risks
Seniority
Junior to Mid-level, hands-on IC