وصف الوظيفة
:Job description
- 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
:Job requirements
- 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-depth knowledge of ISO 13485 and cGMP
- Good clinical practice understanding
- Planning and organizational skills
- Strong communications (written and oral), analytical, quantitative and problem solving skills are required
- 5-10 سنوات خبرة
- مؤهل عالي
- صناعة وزراعة