1. Job Title: Medical Devices Testing Officer (2 Positions)

Job responsibilities

• Receiving and ensuring proper storage of test samples, chemicals, materials and reagents;
• Prepare and standardize solutions, materials and reagents used in laboratory analyses;
• Carrying out tests, interpreting results and calculating uncertainties of measurement especially in cases of marginal test results
• Prepare and maintain a variety of records and reports;
• Participating in the development of new test methods in liaison with the Lead officer
• Maintain inventory of laboratories equipment;
• Maintain the assigned equipment using the manufacturer’s instruction or the applicable work instruction;
• Establish a maintenance plan and request for its implementation.
• Participate in quality control programs and prepare statistical reports;
• Implementing and participating in review of the laboratory quality system.
• Preparation of proposal of technical specification of equipment spares parts and laboratory consumables for purchase;
• Participation in evaluation of new equipment after commissioning
• Maintaining inventories of laboratory supplies.

Minimum qualifications

• Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, Electronics, Physics, Electronical Engineering with 0 Year of relevant experience

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2. Job Title: Pharmaceutical Products Registration Specialist (2 Positions)

Job responsibilities

• To conduct dossier assessment for product registration
• To develop and adopt necessary regulatory tools such as guidelines, SOPs, and official forms within the regulatory framework to standardize and improve the assessment procedures,
• To contribute to the product register updates with variations, new registrations, and deletions due to GMP failure and safety issues,
• To assess bioequivalence of generic pharmaceutical products compared to reference products by reviewing bioequivalence studies,
• To organize samples for and liaise with the Division of Quality Control Laboratory testing and analysis to facilitate product assessment and registration.
• To participate and conduct operational research, programmes, and projects within the Division.
• To demonstrate the ability to consistently provide quality services that meet customer and regulatory requirements within his/her division to meet Rwanda FDA quality objectives.
• To participate in organized training in Quality Management System.
• To do the assigned tasks (job) by fully implementing the QMS established requirements

Minimum qualifications

• Bachelor of Science in Pharmacy, Pharmacy, Pharmaceutical Sciences, Molecular Biology with 3 Years of relevant experience

• Master of Science in Pharmacy, Pharmacy, Molecular Biology, Pharmaceutical Sciences with 1 Years of relevant experience

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3. Job Title: Blood and Blood Products Registration Specialist

Job responsibilities

• To participate in the development, review of the necessary regulatory tools such as regulations, guidelines, SOPs, and official forms within the regulatory framework to standardize and improve the assessment procedures,
• To contribute to the development, review, and updating of the register of blood and blood products with variations, new registrations, and deletions due to safety issues,
• To evaluate the quality, safety and efficacy of blood and blood products
• To sample blood and blood products from the market and liaise with the Division of Quality Control Laboratory for analysis to facilitate assessment and registration,
• To participate in the conduct operational research, programmes and projects within the Division
• To demonstrate the ability to consistently provide quality services that meet customer and regulatory requirements within his/her division to meet Rwanda FDA quality objectives.
• To participate in organized training in Quality Management System.
• To do the assigned tasks (job) by fully implementing the QMS established requirements.

Minimum qualifications

• Bachelor's Degree in Microbiology, Molecular Biology, Pharmaceutical Sciences, Biotechnology, Biomedical Laboratory Sciences, Medicine, Pharmacy with 3 Years of relevant experience

• Master's Degree in Microbiology, Pharmacy, Biotechnology, Biomedical Laboratory Sciences, Molecular Biology, Pharmaceutical Sciences with 1 Years of relevant experience

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4. Job Title: Diagnostics and Medical Devices Registration Specialist

Job responsibilities

• To participate in the develop and review of necessary regulatory tools such as regulations, guidelines, SOPs and official forms within the regulatory framework to standardize and improve the assessment procedures,
• To contribute establishment, review and updating of the register of Human Diagnostics and Medical Devices with variations, new registrations and deletions due safety and quality issues,
• To sample Human Diagnostics and Medical Devices from the market and liaise with the Division of Quality Control Laboratory for analysis,
• To participate and conduct operational research, programmes and projects within the Division
• To demonstrate the ability to consistently provide quality services that meet customer and regulatory requirements within his/her division in order to meet Rwanda FDA quality objectives.
• To participate in organized training in the area of Quality Management System.
• To do the assigned tasks (job) by fully implementing the QMS established requirements.

Minimum qualifications

• Bachelor's Degree in Biomedical Engineering, Pharmacy, Pharmaceutical Sciences, Electronical Engineering, Biomedical Sciences with 3 Years of relevant experience

• Master's Degree in Pharmacy, Electronics Engineering, Biomedical Engineering, Biomedical Sciences, Pharmaceutical Sciences with 1 Years of relevant experience

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5. Job Title: Radiopharmaceuticals & Radiotherapy Products Registration Specialist

Job responsibilities

• To conduct dossier assessment for product registration
• To participate in the develop and review of necessary regulatory tools such as regulations, guidelines, SOPs, and official forms within the regulatory framework to standardize and improve the assessment procedures,
• To contribute establishment, review and updating of the register of radiopharmaceuticals and radiotherapy products with variations, new registrations and deletions due safety and quality issues,
• To sample radiopharmaceuticals and radiotherapy products from the market and liaise with the Division of Quality Control Laboratory for analysis,
• To participate and conduct operational research, programmes and projects within the Division.
• To demonstrate the ability to consistently provide quality services that meet customer and regulatory requirements within his/her division to meet Rwanda FDA quality objectives.
• To participate in organized training in Quality Management System.
• To do the assigned tasks (job) by fully implementing the QMS established requirements.

Minimum qualifications

• Bachelor's Degree in Pharmacy, Chemistry, Human Medicine, Biomedical Sciences with 3 Years of relevant experience

• Master's Degree in Pharmacy, Chemistry, Biomedical Sciences, Medicine with 1 Years of relevant experience

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6. Job Title: Vaccines and Biosimilar Registration Specialist

Job responsibilities

• To participate in the preparation and implementation of business plan and budget for the Division,
• To participate in the development and review of regulations, guidelines, manuals and SOP related to assessment and registration of human vaccines, biologicals and biosimilar and others similar documents that may be needed the Division or Department.
• To contribute to the development, review and updating of the register of human vaccines, biologicals and biosimilar with variations, new registrations and deletions due safety issues,
• To assess human vaccines, biologicals and biosimilar with variations, new registrations, and deletions due safety issues,
• To Evaluate the quality, safety and efficacy of human vaccines, biologicals and biosimilar,
• To Sample of human vaccines, biologicals and biosimilar from the market and liaise with the Division of Quality Control Laboratory for analysis,
• To participate in Conduct of operational research, programmes and projects within the Division

Minimum qualifications

• Bachelor's Degree in Pharmacy, Biotechnology, Pharmaceutical Sciences, Molecular Biology with 3 Years of relevant experience

• Master's Degree in Pharmacy, Biotechnology, Molecular Biology, Pharmaceutical Sciences with 1 Years of relevant experience

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7. Job Title: Controlled Substances Specialist

Job responsibilities

• To screen, assess and prepare feedback to the applications for registration of Controlled Substances.
• To submit samples for testing and ensure that the results are available for use in assessment process.
• To efficiently use resources and ensure the compliance of product registration, review guidelines and to streamline the processes.
• To improve Controlled Substances assessment standard by adopting and harmonizing international standards and best practices.
• To assess product variation applications and propose approvals on changes made to registered products to the Division Manager.
• To demonstrate the ability to consistently provide quality services that meet customer and regulatory requirements within his/her division to meet Rwanda FDA quality objectives.
• To participate in organized training in Quality Management System.
• To do the assigned tasks (job) by fully implementing the QMS established requirements.

Minimum qualifications

• Bachelor's Degree in Pharmacy, Chemistry, Biotechnology, Pharmaceutical Sciences, Human Medicine with 3 Years of relevant experience

• Master's Degree in Pharmacy, Chemistry, Biotechnology, Medicine, Pharmaceutical Sciences with 1 Years of relevant experience

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