Regulatory Affairs Specialist – Medical Devices & IVD

We are seeking a detail-oriented and organized Regulatory Affairs Specialist to support the registration, maintenance, and regulatory compliance of Medical Devices and In Vitro Diagnostic (IVD) products in Saudi Arabia.

Key Responsibilities

• Prepare, review, and follow up on SFDA/MDMA registration, renewal, and update applications.

• Review technical and regulatory documentation to ensure compliance with SFDA requirements.

• Prepare and submit regulatory files, and follow up on SFDA comments, inquiries, and requests for additional information.

• Coordinate with manufacturers and suppliers to obtain missing, updated, or revised regulatory documents.

• Support medical device and IVD product classification and regulatory assessments.

• Maintain accurate records of MDMA applications, registrations, certificates, expiry dates, submissions, and regulatory correspondence.

• Monitor changes and updates to SFDA regulations and requirements, and support ongoing regulatory compliance.

• Coordinate with internal departments on product registration status, regulatory requirements, and documentation.

• Ensure timely follow-up on regulatory actions and maintain accurate regulatory trackers.

Requirements

• Bachelor’s degree in Pharmacy, Biomedical Sciences, Biotechnology, or a related scientific field.

• 1–3 years of experience in Regulatory Affairs, preferably within the Medical Devices or IVD sector.

• Practical knowledge of SFDA requirements and MDMA registration is highly preferred.

• Proficiency in English, both written and spoken.

• Proficiency in Microsoft Office, particularly Excel and Word.

• Strong attention to detail and commitment to document accuracy.

• Excellent organization, communication, coordination, and follow-up skills.

• Ability to manage multiple regulatory files and deadlines simultaneously.

Preferred Qualifications

• Hands-on experience with SFDA medical device registration and MDMA applications.

• Experience working with manufacturers, suppliers, and regulatory authorities.

• Familiarity with medical device and IVD technical documentation and regulatory classifications.