REGULATORY AFFAIRS & QUALITY ASSURANCE (RA/QA) SPECIALIST @ GENIUS CONSULTANCY
Genius Consultancy is looking for a dedicated Regulatory Affairs & Quality Assurance (RA/QA) Specialist to be based in Dar es Salaam, Tanzania. This role involves managing critical TMDA submissions and ensuring that all operations adhere to ISO 13485 Quality Management System standards. The specialist will play a vital part in maintaining production quality assurance and overseeing incoming quality control to ensure that all medical devices and IVDs meet the required regulatory and safety benchmarks. The ideal candidate will be responsible for identifying deviations and implementing robust CAPA (Corrective and Preventive Actions) management systems.
In addition to technical oversight, the role requires collaborating with production teams to streamline quality processes and ensure full compliance with national and international standards. This position offers a unique opportunity for professionals with a pharmaceutical or medical laboratory background to contribute to high-level regulatory affairs within a leading consultancy firm. You will be expected to maintain technical documentation and stay updated with the latest requirements from the Tanzania Medicines and Medical Devices Authority to ensure seamless market entry and compliance for all products under our portfolio.
In addition to technical oversight, the role requires collaborating with production teams to streamline quality processes and ensure full compliance with national and international standards. This position offers a unique opportunity for professionals with a pharmaceutical or medical laboratory background to contribute to high-level regulatory affairs within a leading consultancy firm. You will be expected to maintain technical documentation and stay updated with the latest requirements from the Tanzania Medicines and Medical Devices Authority to ensure seamless market entry and compliance for all products under our portfolio.
Key Requirements
Degree in Pharmacy, Medical Lab Sciences, or related field
2+ Years QA/RA Experience in Medical Devices or IVDs
Comprehensive knowledge of TMDA regulations and ISO 13485 standards
Experience in managing TMDA submissions and ensuring QMS compliance
Proficiency in Production Quality Assurance and Incoming Quality Control (IQC)
Proven experience in Deviations and Corrective and Preventive Actions (CAPA) Management
Strong analytical skills for quality data monitoring and reporting
Excellent communication skills for coordinating with regulatory bodies
High level of integrity and attention to detail in quality reporting
Ability to prepare and maintain technical documentation for medical products