Assistant Researcher II

Quality Management / Assurance / Regulatory Affairs Officer– Immunoassay Clinical Validation with a Position of Assistant Researcher II  About Us  The Armauer Hansen Research Institute (AHRI) was founded in 1970 through the initiative of the Norwegian and Swedish Save the Children organizations seconded by the Ministry of Health of Ethiopia. The Institute got its name from the Norwegian physician, XXXX XXXX, who first described the leprosy bacillus (Mycobacterium leprae). AHRI is a biomedical research institute that works in developing tools for prevention, control and treatment of mycobacterium and other diseases of public health importance through applied and basic biomedical research and training.   About the job  Immediate Job Vacancy Announcement  Position:  Assistant Researcher II-Quality Management, Assurance/ Regulatory Affairs Specialist

• IVD (Assistant Researcher II)  Purpose of the Position  Armauer Hansen Research Institute (AHRI) is seeking a qualified and motivated professional to support the clinical validation and regulatory approval process of diagnostics and other diagnostics related products in line with established quality standards and regulatory requirements and to lead the preparation of Ethiopian Food and Drug Authority (EFDA)‑compliant regulatory documentation. The successful candidate will work closely with the Principal Investigator (PI) and research team to ensure that all validation and regulatory processes meet national and international standards. The candidates shall also ensure the compliance of QMS and GLP in the Research, Development and Diagnostic Incubation Center laboratories with close collaboration with the Research Team, Quality Management and Biosafety/Biosecurity Team. Directorate/Division : Communicable and Non-Communicable Disease Research Directorate-Viral Disease Research Division  Major Duties and Responsibilities  Work closely with the PIs and co‑investigators to support the  clinical validation  of diagnostic and diagnostic related products and in accordance with EFDA expectations and AHRI quality systems.  Prepare, organize, and finalize all documents required for  EFDA IVD registration,  including analytical and clinical validation summaries, SOPs, risk assessments, labeling materials, and quality records.  Ensure that validation activities align with  EFDA’s current IVD regulatory  requirements,  considering Ethiopia’s diagnostic market realities and available resources.  Coordinate with the research team to ensure proper execution and documentation of validation procedures  Maintain clear, systematic records of validation data, assay performance metrics, and regulatory correspondence.  Participate in project meetings, provide progress updates, and contribute to scientific and regulatory reports.  Liaise with EFDA and relevant institutional offices to support timely review and approval of regulatory submissions.  Perform other related duties assigned by the PI or AHRI scientific leadership.  Accountability  The employee will report directly to the Principal Investigator (PI) and collaborate closely with AHRI’s scientific and regulatory teams under Viral Disease Research Division of the Communicable and Non-Communicable Disease Research Directorate