Regulatory Affairs & Quality Assurance Senior Specialist
Skills
About This Role
I. Regulatory Affairs
- Act as one of the main points of contact for SFDA and be responsible for Imdad s products.
- Report the status of the products and related tasks on a monthly basis.
- Ensure that the equipment is in compliance with SFDA regulations.
- Follow up with logistics for the importation of Imdad s products including Equipment, Accessories and cosmetics.
- Obtain Faseh & Nnjzha approval for logistics to ensure compliant importation of products.
- Ensure approval of product registration applications for equipment, cosmetics, and accessories in KSA.
- Ensure the update of registrations in accordance with relevant legislation, regulations, and guidelines.
- Prepare complete registration dossiers for all products, including reviewing and verifying their compliance with SFDA requirements and regulations.
- Coordinate with suppliers regarding equipment specifications and documentation.
- Review and validate all documents before submission to SFDA.
- Track and ensure that applicable fees are paid on time and all licenses are renewed in a timely manner.
- Support other internal departments with regulatory requests and complaints.
- Monitor updates to SFDA regulations, guidelines, and circulars, assess their impact on company products, and ensure timely implementation of required changes.
II. Quality Assurance
- Ensure that the QMS processes are established, implemented, and maintained.
- Report to the direct manager on how well or poorly the QMS is performing.
- Regularly review the QMS objectives.
- Maintain appropriate records.
- Ensure that all Good Distribution and Storage Practices are applied.
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