Regulatory Affairs Supervisor
GMS -
Bourj Alarab, AlexandriaPosted 4 years ago21Applicants for1 open position
- 11Viewed
- 8In Consideration
- 0Not Selected
Job Details
Experience Needed:
Career Level:
Education Level:
Salary:
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Skills And Tools:
Job Description
Main duties:
- Generation/update of registration procedures relevant to regulatory compliance and registration activities based on the regulatory requirements.
- Collection of data and documents required for registration from the relevant departments.
- Compilation of registration/re-registration/importation files inside and outside Egypt.
- Submission and follow-up of registration files with competent authorities inside and outside Egypt in the required timelines.
- Compliance with applicable regulations and laws required by national and international authorities.
- Share in review of the technical documentation and the EU declaration of conformity.
- Share in review of the post-market surveillance execution documents.
- Share in review of "Vigilance System" reports.
- Participate in internal audits as per the audit program.
- Share in risk management, change control and handling of deviations, whenever required.
Job Requirements
Experience:
- 2 to 3 years' regulatory experience or
- 4-5 years' Quality Assurance experience
- Company Industry: Medical Devices & Pharma
- Location: based Alexandria
- Education: graduate from faculty of Sciences or Pharmacy.
Skills:
- Very good computer and language skills.
- Very good communication/presentation skills.
Abilities:
- Ability for domestic travel.
- Ability for accepting new ideas and adapting to new assignments.
- Problem solving skills.
- Able to work effectively and efficiently with others
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