Medical Devices Vigilance Specialist

About the role

The Medical Devices Vigilance Specialist ensures that all safety and regulatory activities for medical devices registered in Egypt comply with local regulations, company policies, and global standards. This role serves as the primary liaison with health authorities and supports regional and global product surveillance efforts.

Key responsibilities

• Collect and communicate local medical device regulatory updates to the regional surveillance team.
• Establish and maintain a local vigilance system aligned with Egyptian regulations.
• Develop, draft, and maintain SOPs and work instructions that meet local and international requirements.
• Coordinate field safety notices, corrective actions, and recalls with health authorities.
• Act as the main contact during local audits and inspections, handling communications and audit reports.
• Collaborate with local regulatory affairs and health authority officials to prepare and submit required vigilance documents.
• Track document approvals, manage timelines, and ensure accurate submissions to the Medical Devices Safety Department.

Required profile

• Strong knowledge of Egyptian medical device regulations and global vigilance standards.
• Experience in preparing and submitting regulatory documents to health authorities.
• Excellent communication skills for interaction with internal teams and external regulators.
• Ability to manage audits, inspections, and corrective actions effectively.

Required skills