Regulatory Affairs - Riyadh, المملكة العربية السعودية - Imdad

وصف

Regulatory Affairs Specialist acts as the liaison between the company and regulatory authorities (SFDA) to ensure that imported products are manufactured and distributed in compliance with appropriate governmental legislation.

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 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.
• Obtain Faseh Approval for logistics to ensure compliant importation of Imdad's 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.
• Track and ensure that applicable fees are paid on time and all licenses are renewed in a timely manner.

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.

• Bachelor's degree in biomedical engineering or any related Medical Scientific Field
• Minimum 1 year of experience in Regulatory Affairs

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• Excellent communication skills (oral & written), and ability to work well in a team.
• Time Management skills.
• Good computer skills (MS. Office, Excel & Outlook)
• Excellent organization skills.
• Excellent Arabic and English skills (Written & spoken).