Regulatory Affairs & Quality Assurance Section Head
MED VICE -
10th of Ramadan City, SharqiaPosted 10 months ago52Applicants for1 open position
- 23Viewed
- 7In Consideration
- 0Not Selected
Job Details
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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 medical devices industry
- 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
- Preferably 10th of Ramadan city resident
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