Quality Assurance / Regulatory Affairs Specialist – Immunoassay Clinical Validation (Associate Researcher I)

About the Position

Armauer Hansen Research Institute (AHRI) is seeking a qualified and motivated professional to support the clinical validation and small-scale use of the Strengthening Health Innovation Network in Ethiopia (SHINE)-supported HBsAg detection immunoassay. The role focuses on ensuring compliance with established quality standards and regulatory requirements, and leading 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.

Major Duties and Responsibilities

• Work closely with the PI and co-investigators to support the clinical validation of the HBsAg IVD immunoassay 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

Reporting Structure

The employee will report directly to the Principal Investigator (PI) and collaborate with the research team.

Location

Addis Ababa, Ethiopia