Job Details
Experience Needed:
Career Level:
Education Level:
Salary:
Job Categories:
Skills And Tools:
Job Description
- Create a conceptual design for the factory including (production area (clean room)- labs- warehouse -any other related facility) according to MOH, CE, FDA regulations.
- Deal with Egyptian Drug Authority for all the procedures to acquire the final registration and qualifying the factory for acquiring CE, FDA, and ISO13845
- Prepare and attend the meetings of any committee related to the design or any technical meeting related to the license from the medical perspective
- Verify and assure the classification of a medical device according to the latest approved directive from the Egyptian drug authority, EEC, FDA
- Acquire CE, FDA certificates for the products and any other related tasks Prepare the procedures and the files of the related tests of the product
- Prepare the following files:
- Product license with Egyptian drug authority
- Import the machines file and its approvals from MOH or any other governmental entity
- Sterilization – Irradiation Validation
Job Requirements
- Bachelor’s Degree in Pharmacy/ Science/biomedical engineering.
- Able to travel to different locations inside Egypt.
- Planning and project management skills.
- Ability to use designing apps.
- Good communication skills.
- Aware of the latest versions and updates of the medical directives.
- Excellent English and computer skills.
- Previous experience with establishing a medical device factory is a must.
Featured Jobs
Similar Jobs
- Toll Manufacture Senior Specia...Al Andalous Pharmaceutical Industries - 6th of October, Giza10 days ago