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Regulatory Affairs & Quality Ass...

MED VICE
10th of Ramadan City, Sharqia

Regulatory Affairs & Quality Assurance Section Head

10th of Ramadan City, SharqiaPosted 1 month ago
48Applicants 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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