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Job Description
- Contribute to the development of processes, procedures, methodologies, and systems relevant to the work area, including preparation of appropriate documentation of reports.
- Collect, collate, follow up, process, evaluate and analyze the Incident Reports (IR) for medical devices submitted by healthcare professionals, patients
- Responsible for managing registration process, reregistration, variation
- Responsible for assuring registration files preparation completion of medical devices products imported products for new submission or reregistration.
- Follow up all the steps of registration and reregistration steps for
- Responsible for coordinating with the dept. managers for product’s status and date of release.
- Ensure a brief comprehensive data reached for all over the company departments with all the product status and steps related to reach their launching date for every product.
- Ensure no cancellation of registrations/licenses due to regulatory non-compliance
- Maintain an Effective Communication Network with Ministry of Health Authorities
- Corporate with sales teams setting priorities for needed registrations priorities
- Managing for submitting vigilance files related to products registration
- Follow up customers’ complaints communication to suppliers till complaints are closed.
- Prepare, follow up & submit Vigilance products documents, recalls, FSNs, PSRs and FSAs authorities till issues are closed.
- Develops Medical Device Vigilance System guideline.
- Review the new suppliers’ agreement terms and certificates.
Job Requirements
Job Requirements
- Bachelor’s Degree in Science, Chemistry, Biochemistry, Pharmacology, Biology, or related field; or an equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job required
- Planning and organizational skills.
- 8 to 10 years at least of experience in the same role
- Speaks and writes English fluently
- Business Background is preferred
- SAP experience is a Must
- Prefer Medical devices or pharmaceutical industry
- Exceptional leadership, communication, and interpersonal skills.
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