Regulatory Affairs Associate

Role Overview

The Regulatory Affairs Associate will support compliance activities related to SFDA requirements for medical device registration and post-market surveillance. This role focuses on understanding regulatory expectations, preparing and tracking submissions, coordinating with clients and authorities, and maintaining accurate regulatory records.

Key Responsibilities

• Build and continuously update knowledge of SFDA regulations, including the ability to identify and interpret relevant guidance.
• Review regulatory updates or rule changes and help translate them into internal company procedures and policies.
• Advise on procedural updates needed when regulations or standards change.
• Assess what submissions or internal records are required for cases such as product modifications or document updates.
• Check initial documents for compliance with the applicable requirements.
• Communicate with clients regarding technical documentation and related regulatory matters.
• Prepare and submit the required applications to SFDA for the relevant process, then monitor progress and respond to SFDA queries.
• Liaise with and, when necessary, visit SFDA offices to support the process.
• Follow up with clients within 2 to 3 days as needed.
• Participate in client meetings whenever required.
• Maintain clear records of work completed for each client and manage the associated information.
• Draft responses to requests for product information, regulatory statements, surveys, and questionnaires.
• Keep daily tracking sheets up to date.
• Organize and maintain regulatory document databases and related systems.
• Provide support to managers and team members.
• Report directly to the Head of the IVD & Establishment Registration Department.
• Take part in internal regulatory training sessions.
• Follow company policies and procedures carefully at all times.

Requirements

• A bachelor’s degree in a relevant discipline such as Medical Laboratory or Biochemistry.
• Strong spoken and written communication skills in both Arabic and English.
• High attention to detail and accuracy.
• Familiarity with the Saudi Arabian and international healthcare market.

Additional Information

This is a full-time, on-site position based in the Riyadh Region. The role involves regular coordination with clients and regulatory authorities, along with documentation tracking and compliance support.