The Zambia Medicines Regulatory Authority (ZAMRA)\u00a0is a statutory body established under the Medicines and Allied Substances Act (No. 3) of 2013, responsible for the regulation of medicine and allied substances in Zambia. The Authority invites applications from suitably qualified Zambian citizens who are ambitious, innovative, energetic, and performance-driven to apply for various positions as follows:
\nJob posting service<\/p>\n
POSITION: REGISTRATION OFFICER \u2013 MEDICAL DEVICES (2)
\nJOB TYPE:\u00a0FULL TIMELOCATION:\u00a0LUSAKA<\/p>\n
Job Purpose
\nThe Registration Officer \u2013 Medical Devices shall be responsible to ensure the registration of safe, effective, and quality medical devices and diagnostics on the Zambian market.<\/p>\n
Person Specifications and Qualifications
\na) Full Form V\/ Grade 12 School Certificate (including English and Mathematics);b) Bachelor\u2019s degree in Pharmacy, BSc in Biomedicines, or a similar discipline;c) At least 2-3 years of experience in Medical Devices regulation, or a related field; andd) Membership to relevant professional body.<\/p>\n
Skills:<\/p>\n
Strong analytical and problem-solving skills;<\/p>\n
Excellent written and verbal communication skills;<\/p>\n
Ability to work independently and as part of a team;<\/p>\n
Proficiency in data analysis and reporting;<\/p>\n
Knowledge of medical regulations, guidelines, and best practices; and<\/p>\n
Familiarity with database management systems and software used in medical devices regulation.<\/p>\n
Duties and Responsibilities
\na) Undertake the registration of medical devices for human and animal use in order to achieve compliance to set standards;b) Participate in formal and informal information-sharing networks with other regulatory authorities in order to allow earlier detection of a potential problem than would be possible within a single jurisdiction and facilitate reliance upon and confidence building with other regulatory authorities;c) Undertake dossier assessments of summary technical information of devices applied for marketing approval in order to comply with the essential Principals of Safety and Performance;d) Undertake development and review of regulations and guidelines for medical devices and diagnostics registration in order to ensure compliance;e) Coordinate the performance evaluation of In Vitro Diagnostics in order to ensure compliance to set standards;f) Maintain a medical device and diagnostics register in order to provide information to stakeholders;g) Coordinate the Technical Committee meetings on recommendation of medical devices and diagnostics registration; andh) Undertake the maintenance of the medical devices information management system in order to facilitate storage, processing, retrieval, and dissemination of information.
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