SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES

​TECHNICAL OFFICER: MEDICAL DEVICES - VIGILANCE (GRADE 1) 
(FIXED-TERM CONTRACT POSITION UNTIL 31 MARCH 2028) 
Ref No.: SAHPRA 43/2025 
SALARY: R 738 611.00 – R783 939.00 per annum (TOTAL COST TO COMPANY) 
 
REQUIREMENTS: Matric certificate and four-year degree in Pharmacy or Honours degree in Natural/Medical Sciences/Clinical Engineering at NQF level 8 as recognised by the South African Qualifications Authority (SAQA). Registration with the relevant professional body. 
 
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 Licencing, Vigilance and Post Marketing Surveillance requirements. 
 
CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: Comprehensive knowledge and understanding of relevant legislation, the Medicine and Related Substances Act 101 of 1965 (as amended), Regulations relating to Medical Devices and IVDs. Computer literacy and MS Windows computer skills, Excel, and database applications. Good report writing and presentation skills. Good planning and organisational skills. Good verbal and written communication skills. Self-motivated and able to work independently. Ability to manage a variety of cross-functional team members. Pay attention to detail and information evaluation. Ethical behaviour and adherence to the SAHPRA Code of Conduct. At SAHPRA, we adhere to our core values: ubuntu, responsiveness, integrity, transparency, efficiency, collaboration, and excellence. 
 
DUTIES
Perform risk-based evaluation of vigilance reports for medical devices and IVDs. Manage further handling of vigilance activities and maintain relevant databases. Develop and maintain guidelines and standard operating procedures for Medical Devices Licensing and Vigilance. Evaluate and manage licence applications for medical device establishments and maintain relevant databases. Prepare reports for SAHPRA and relevant advisory committees. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit. Liaise with international regulatory authorities. Communicate with the members from industry regarding the SAHPRA Board resolutions, legislative requirements for medical devices, and IVDs. Investigate and attend to industry/applicant’s 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. 
 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): 

• Interested persons who meet the above-stated requirements should submit their application, clearly state the position name and post reference number, including a signed cover letter, clearly state the position name and post reference number detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, and copies of required qualifications (including matric). ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview, following communication from Human Resources. 
• Should you have a foreign qualification, your application must be accompanied by an evaluation certificate (report) from SAQA. 
• Incomplete applications or applications without the aforementioned documents or information will not be considered. 
• No late applications will be accepted. Any submissions received after the specified date and time will not be considered, and CVs will not be returned. 
• Due to the larger number of responses anticipated, communication will be limited to short-listed candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider their application unsuccessful. 
• Shortlisted candidates will be expected to attend selection interviews at a date, time, and location as specified by SAHPRA. 
• Applicants should note that pre-suitability checks will be conducted after they have been shortlisted. Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience. 
• SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the Republic of South Africa, Act 108 of 1996, and the Employment Equity Act, 55 of 1998. Applicants with disabilities are encouraged to apply and indicate their disability status, which will be appreciated. 
• SAHPRA reserves the right not to make any appointment(s) to the advertised post(s). 
• SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013. CVs will not be returned, as the personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your purposes. 
• Applications should be submitted through the SAHPRA Website Online Portal: https://www.sahpra.org.za/vacancies.
• For enquiries: Please contact Mr T Khunou, HR Business Partner, via email at Tshepo.Khunou@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS. 
• The closing date is 07 November 2025 at 16:00.

​TECHNICAL SCREENER 
(HEALTH PRODUCTS AUTHORISATIONS) 
SALARY: R563 996.00 – R598 626.00 PER ANNUM (TOTAL COST TO COMPANY) 
Ref No.: SAHPRA 44/2025 
CENTRE: PRETORIA 
 
REQUIREMENTS: Matric certificate and an appropriate 3-year Bachelor of Science Degree at NQF level 7 as recognised by SAQA (Appropriate 4-year degree in Chemistry/Pharmacology or Bachelor of Pharmacy will be an advantage), and registration with a statutory council if applicable. Three (3) years of relevant regulatory experience. Experience in product review or assessments will be an added advantage. 
 
COMPETENCIES:

• Knowledge and good understanding: Theoretical knowledge of technical aspects for the evaluation of medicines across all fields, namely: Medicines and Related Substances Act (101 of 1965). Safety and efficacy. Quality and bioequivalence. Naming and scheduling. Good Manufacturing Practice. Knowledge of the regulatory environment. Good Clinical Practice. Pharmacovigilance. 
• Skills: Comfort working with computers and computer software packages. Displays a strong academic background. Good and effective communication skills (written and verbal). Planning and coordination skills. Conflict management. Critical thinking and problem-solving skills. Self-Management. 
• Attributes: Able to remain self-motivated with the ability to work independently. Positive attitude. Team player. Ability to work precisely and efficiently. Ethical behaviour and adherence to the SAHPRA Code of Conduct. Flexible. Deadline driven. Honest. Ability to prioritise and display excellent time management skills. Ability to work under pressure. Ability to tolerate stress. Responsiveness. Relationship management. 

 
DUTIES: Technical screening of medicines applications: * Assess each module of the application against the relevant technical screening form to ensure they are appropriate in terms of format and content as defined by the relevant guidelines.* Generate a validation report and submit to the portfolio coordinator for peer review/ sign-off. * Generate a list of queries to the applicant for applications that do not comply with applicable guidelines. * Complete and sign a technical screening outcome report within target timelines. * Communicate the technical screening outcome to the Evaluator Co-ordinator. * Conduct peer review of technical screening report (s) done by other technical screeners. * Save the relevant reports in the folder structure for the specific application. * Conduct technical screening, assign classifications, and review pathways for new medicines registration and/ or variations when backup support is required by the business. * . Timely assessment and identification of medicine safety issues or signals stemming from pharmacovigilance recommendations. * Source reliance reports from the relevant Recognised Regulatory Authority (RRA) via the focal person. * Identify and confirm applications for internal reliance and capture on the screening outcome report and on the Tracker. 
Technical screening of query responses: * Assess each module of the application against the relevant technical screening form to ensure they are appropriate in terms of format and content as defined by the relevant guidelines. * Generate a validation report and submit to the portfolio coordinator for peer review/ sign-off. * Generate a list of queries to the applicant for query responses that do not comply with applicable guidelines.* Complete and sign a technical screening outcome report within target timelines. * Communicate the technical screening outcome to the Evaluator Co-ordinator.* Conduct peer review of technical screening report (s) done by other technical screeners. * Save the relevant reports in the folder structure for the specific application. 
Track and convey statuses to Portfolio coordinator: * Capture outcome of the screening and completion date on the Tracker/database. * Provide relevant statistics and evidence for Performance Reporting monthly. * Identify and report on trends for decision making. 
Management of risk and audit queries: * Adherence to standard operating procedures and SAHPRA guidelines. * Ensuring that SOPs are maintained. * Attend relevant training to support your function. 
* Respond to queries and non-conformances raised by internal and external stakeholders. * Support units with QMS internal and external audits, including ISO 9001:2015 certification. 
Stakeholder management: * Liaise with Evaluator Coordinators regarding allocations of screening applications and ensure that Portfolio Coordinators are kept updated on the status of applications. 
People management: * Manages own time, deliverables to ensure that they contribute to the team’s outputs. * Completes validation reports and query letters. 
Finance: Applies the organisation policies and complies with procurement and finance procedures.
 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): 

• Interested persons who meet the above-stated requirements should submit their application, clearly state the position name and post reference number, including a signed cover letter, clearly state the position name and post reference number, detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, copies of required qualifications (including matric) and Identity Document. ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview, following communication from Human Resources. 

• Should you have a foreign qualification, your application must be accompanied by an evaluation certificate (report) from SAQA. 
• Incomplete applications or applications without the aforementioned documents or information will not be considered. 
• No late applications will be accepted. Any submissions received after the specified date and time will not be considered, and CVs will not be returned. 
• Due to the larger number of responses anticipated, communication will be limited to short-listed candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider their application unsuccessful. 
• Shortlisted candidates will be expected to attend selection interviews at a date, time, and location as specified by SAHPRA. 
• Applicants should note that pre-suitability checks will be conducted after they have been shortlisted. Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience. 
• SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the  Republic of South Africa (1996), the Employment Equity Act, 55 of 1998. Applicants with disabilities are encouraged to apply and indicate their disability status, which will be appreciated. 
• SAHPRA reserves the right not to make any appointment(s) to the advertised post(s). 
• SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013. CVs will not be returned, as the personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your application is unsuccessful, your personal information will be retained for internal audit purposes. 
• Applications should be submitted through the SAHPRA Website Online Portal: SAHPRA website (https://www.sahpra.org.za/vacancies) / Portal Link (https://apply.sahpra.org.za:6006/).
• For enquiries: Please contact Ms Setlola Molepo, via email at setlola.molepo@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS. 
• The closing date is 07 November 2025 at 16H00.