The Regulatory Affairs Officer Medical Diagnostic Devices is responsible for managing the preparation, submission and lifecycle maintenance of regulatory dossiers for in vitro diagnostic (IVD) devices in compliance with national and international regulations including NDA Uganda, ISO 13485, WHO, and other relevant authorities. The officer will coordinate technical document compilation, facilitate audits, track submission timelines and ensure that all product labeling, claims and documentation meet regulatory standards. The ideal candidate must possess solid knowledge of regulatory frameworks for IVDs and medical devices and have experience in coordinating product registrations and regulatory correspondence for diagnostics.

Key Duties and Responsibilities:

1. Prepare and submit regulatory dossiers for medical diagnostic devices in CTD or device-specific formats to local and global authorities.
2. Ensure compliance with ISO 13485, WHO PQDx, and national regulations related to IVD classification, registration and post-market surveillance.
3. Maintain up-to-date regulatory documentation, technical files, and labeling in accordance with product lifecycle requirements.
4. Coordinate with product development, QC, QA, and manufacturing teams to gather and validate regulatory data.
5. Track and respond to regulatory queries, deficiency letters and changes in submission status.
6. Manage product renewals, variation applications and regulatory updates.
7. Review product labeling, instructions for use (IFUs), and promotional materials for regulatory compliance.
8. Prepare for and support GMP audits, WHO inspections, and internal regulatory reviews.
9. Monitor changes in regulatory guidelines and communicate implications to relevant departments.
10. Participate in internal regulatory training and contribute to continuous improvement of compliance systems.

Academic Qualifications:
Bachelor’s degree in Biomedical Engineering, Medical Laboratory Technology, Regulatory Affairs, or a related discipline. Certification in Regulatory Affairs or ISO 13485 is an added advantage.

Experience and Competencies:

1. Minimum of 3–5 years of regulatory experience in medical devices or IVDs, preferably with a manufacturing or diagnostic firm.
2. Familiarity with ISO 13485, EU IVDR, WHO PQDx and local NDA guidelines for diagnostics.
3. Hands-on experience with technical documentation, product classification, and regulatory submissions.
4. Strong organizational, documentation and analytical skills.
5. Excellent communication and coordination skills across cross-functional teams.
6. Proficiency in Microsoft Office and document control systems.