Job Purpose

The position is responsible for the day-to-day regulatory activities of implementing standards, procedures, and guidelines to ensure the quality, safety, and efficacy of health products and technologies, and that pharmacy professionals are competent and fit to practice.

Duties and Responsibilities

• Support implementation of guidelines, standards, infrastructure, procedures, and tools for medical devices
• Support implementation of quality management systems and risk-benefit strategies regarding quality systems requirements for medical devices, risk management principles, and ISO 13485 standards
• Compile a list of Medical Devices and In-Vitro Diagnostics recommended for granting, withdrawal, suspension, renewal, and revocation of marketing authorization
• Maintain a register of all authorized Medical Devices and In-Vitro Diagnostics
• Participate in publishing lists of authorized or registered Medical Devices and In-Vitro Diagnostics with marketing authorizations
• Implement international guidelines, standards, and tools for post-market surveillance, risk management, advertising and promotional regulations, and supervision of reprocessing single-use medical devices
• Evaluate applications for marketing authorization of Medical Devices and In-Vitro Diagnostics supplied to the public
• Recommend the list of Medical Devices and In-Vitro Diagnostics approved for export
• Participate in capacity development programs related to evaluation, registration, retention, and renewal of Medical Devices and In-Vitro Diagnostics

Person Specifications

For appointment to this grade, a candidate must:

• Have a Bachelor’s Degree in Biomedical Engineering or other health science degree or its equivalent qualification from a recognized institution
• Experience in regulation of medical devices and In-Vitro Diagnostics will be an added advantage
• Hold a professional qualification and membership to a professional body, where applicable
• Be proficient in computer knowledge and skills
• Have good analytical and communication skills
• Fulfil the requirements of Chapter Six of the Constitution