- Maintain compliance with all company policies and procedures
- Leading/attending inspections and executing CAPA plans
- Review and lead the document control process in compliance with all company standard
- Manage the Complaint Handling process and Medical Device Reporting activities.
- Communicate with all regulatory authorities; local & international
- Prepare medical devices technical files in accordance with EDA regulations
- Plan and manage internal audit activities and coordinates audit corrective actions.
- Supervise inspectors and Quality Specialists in daily quality activities
Bachelor’s Degree in life Sciences (Science, Pharmacy, Veterinary or any related field)+5 years at least of experience in Quality assurance and regulatory affairs rules in medical devices industryIn-depth knowledge of ISO 13485 and cGMPGood clinical practice understandingPlanning and organizational skillsStrong communications (written and oral), analytical, quantitative and problem solving skills are requiredPreferably 10th of Ramadan city resident