Regulatory Affairs Executive/Specialist

MINDFREE Consulting | Insurance Talent Hub; Riyadh; On-site; SAR 200,000 - 300,000; Full time

Job summary

A consulting firm in Riyadh is looking for a Regulatory Affairs Specialist to ensure compliance with SFDA regulations for medical devices. The successful candidate will hold a bachelor's degree and have at least 2 years of experience in regulatory affairs. Key skills include excellent communication in English and Arabic, proficiency in MS Office, and knowledge of the Saber and Ghad systems. The role requires document preparation for registrations and liaising with suppliers about importation rules, working from Sunday to Thursday, 8 am to 5 pm.

Qualifications

• 2+ years of relevant experience in Regulatory Affairs of Medical Devices.

Responsibilities

• Ensure products comply with SFDA regulations.
• Keep up to date with changes in regulatory legislation.
• Liaise with regulatory authorities for product registration.
• Prepare documents for product classification and registration.
• Communicate importation rules to suppliers.
• Assist in preparing for internal and external audits.

Skills

Excellent Communication skills (English & Arabic)

Good MS Office skills

Knowledge about Saber System & Ghad System

Knowledge in SFDA regulations

Education

Bachelor's degree

Job description

Accountabilities

Regulatory Affairs:

• Ensure that Zahrawis products comply with the regulations of the SFDA.
• Keep up to date with the latest changes in regulatory legislation and guidelines.
• Liaise and negotiate with regulatory authority to ensure a smooth registration process.
• Provide advice about regulations to customers/suppliers.
• Analyze product complaints and make recommendations to solve the problem and to avoid them in the future.

Product Classification & Registration:

• Ensure that all required documents and actions for Product Classification/Manufacturing Site Registration and Product Registration are available.
• Prepare all required documents to be submitted for Product Classification under SFDA.
• Prepare all required documents to be submitted for Manufacturing Site registration under SFDA.
• Prepare all the Dossiers to be submitted to SFDA for medical, pharmaceuticals and GSL products.
• Prepare and submit samples to SFDA for product registration completion.
• Collect all necessary documents from Supplier to submit for SFDA of products under Ghad System.
• Register reagents with restricted elements through Ghad System.

Importation Permits:

• Prepare and apply for the pre-permit document as per the SFDA guidelines and verify the items being imported and the documents required.
• Apply for the MOH Narcotics and Pre-cursor Chemical permits on the SFDA website as per the specified guidelines.
• Register and submit the permits through Ghad system.
• Resubmit any permits that have not been approved and make sure all the information provided is correct and attach any new documents if required.
• Prepare weekly / monthly report regarding the rejections/ delays for SFDA importation permits and reasons related to that.
• Check and review the safety data sheet of the restricted element to prepare the required documents for obtaining MOI approval.

Exportation Permits:

• Prepare the required documents necessary for obtaining SFDA approval to export medical products outside KSA.

Importation Rules & Regulations:

• Communicate with the existing and new suppliers regarding SFDA importation rules and policies.
• Upload on the SFDA importation system any new classifications or registration certificates.
• Ensure that all urgent request from the Sales team and suppliers are dealt with in a fast manner and ensure that all documents are in place.
• Report any deviation from SFDA guidelines of imported shipments and take the corrective and preventive action accordingly.
• Review on a regular basis the SFDA importation process of distribution agreements.
• Ensure that the SFDA license is renewed before expiry date to avoid importation disturbance.
• Segregate the imported products as per HS code in coordination with logistic team and confirm if products are SFDA regulated or not.
• Coordinate with the Procurement & Logistics Team to update all the required documents in time to avoid importation rejections.

Audit:

• Prepare any documentation needed for internal and external audits.
• File all documents in the corresponding files to ensure all are available and are correct.
• Evaluate the suggestions after the audit and implement them when possible.

Admin:

• Assist the Warehouse Coordinators with relevant documents when requested.
• Coordinate with the Procurement team and assist them with any question they or the Suppliers may have related to SFDA importation.

Requirements

• Education: Bachelors degree.
• Experience: 2+ years of relevant experience in Regulatory Affairs of Medical Devices
• Job Specific Skills: Excellent Communication skills (English & Arabic), Good MS. Office skills, Knowledge about Saber System & Ghad System - Knowledge in SFDA regulations.
• Office Duty: Sunday till Thursday (from 8:00 am 5:00 pm)