: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