The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances,...
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Technical Officer: Medical Devices Compliance (Grade 1)
Matric certificate plus a Natural/ Medical Sciences/Clinical engineering/Pharmacy degree (NQF level 8). Registration with the relevant professional body. A postgraduate qualification will be an added advantage.
EXPERIENCE:
Minimum three (3) years’ experience, of which two (2) years must be regulatory in Medical Devices and IVDs. Knowledge and/or understanding of Medical Devices Regulatory Compliance, QMS and Medical Devices licencing legislative requirements.
DUTIES:
Evaluate and manage licence applications for medical device establishments and maintain relevant databases. Prepare reports for SAHPRA and relevant advisory committees for compliance-related matters. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit. Liaise with international provisions of the Medicines Act and other related Health Acts regarding medical devices and IVDs. Develop and review guidelines and standard operating procedures for Medical Devices Licensing. Proactively audit processes, practices, guidelines, and standard operating procedures for Medical Devices Licensing. Acts as contact person and liaison between Regulatory Compliance, QMS, and Medical Devices Licensing.
Facilitate training of Medical Devices Licensing staff on matters related to any legal changes and updates to compliance guidelines. Investigate complaints from Regulatory Compliance for any transgressions against the Medicines Act and other related Health Acts regarding medical devices and IVDs. Communicate with the members from industry regarding the SAHPRA Board resolutions, legislative requirements for medical devices and IVDs. Investigate and attend to industry/applicants’ queries. Capture and maintain data relating to measuring and monitoring of performance metrics and peer-reviewed reports, and record statistics generated. Manage the associated risks and audit queries, and correspondence from applicants and stakeholders. Submit a weekly work plan and output to the Unit manager (quantitative and qualitative reports). Perform other related functions that may arise from time to time.
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