SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)

The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 101 of 1965, as amended, to monitor, evaluate, regulate, investigate, inspect, register and control medicines, schedule substances, clinical trials and medical devices, including IVDs, and related matters in the public interest. 

SENIOR MANAGER: MEDICAL DEVICES AND RADIATION CONTROL 

SALARY: R1 346 400 – R1 668 400 (A TOTAL COST TO COMPANY PACKAGE) 

REF NO.: SAHPRA 30 OF 2026/27 (5-YEAR CONTRACT) 

CENTRE: PRETORIA 

REQUIREMENTS: A Matric certificate and an appropriate Master’s degree in Biomedical Engineering or Pharmacy or Clinical Engineering or Medical Physics, or a related equivalent qualification at NQF Level 9, as recognised by the South African Qualifications Authority (SAQA). A management qualification such as a Master of Business Administration (MBA), Master of Business Leadership (MBL), or a Management Advancement Programme (MAP) will be an added advantage. A valid driver’s licence is required, as the position involves travel. 

MANDATORY EXPERIENCE A minimum of ten (10) years’ relevant experience in the medical devices and/or radiation control regulatory environment, of which at least five (5) years must be at a management level (Levels 12–13) supporting business operations. Experience of two (2) years at a senior management level (Levels 13–14) will be an added advantage. Extensive knowledge and practical application of the Medicines and Related Substances Act No. 101 of 1965 as amended, and its Regulations; the Hazardous Substances Act No. 15 of 1973; and the National Health Act No. 61 of 2003 are required. Proven experience in project management and stakeholder management is essential. 

REQUIRED KNOWLEDGE SKILLS, ABILITIES, AND COMPETENCIES: *Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. *Sound and in- depth knowledge of the Medicines and Related Substances Act No. 101 of 1965 as amended and the regulations pertaining to the Act and the Hazardous Substances Act No. 15 of 1973 and its regulations. *Sound knowledge of regulatory scientific and technical requirement (to assess the quality, safety and efficacy and or performance aspect). *Sound and in-depth knowledge of the administrative processes for regulation of the medical devices, radionuclides and electronic generation of ionizing and non-ionizing radiation in the Republic of South Africa. *Good understanding of the medical device and radiation industry. *Detailed knowledge of various international standards and norms *Knowledge of complaint management system. *A track record in preparation and management of strategic plans, annual performance and operational plans *Knowledge of budgeting and financial management system. *Broad knowledge of the Public Finance Management Act, 1999 (Act 1 of 1999) (PFMA), Labour Relations Act, 1966 (Act 66 of 1995) and the Employment Equity Act, 1998 (Act 55 of 1998). *General management including Human Resources, budgeting and financial management skills. *Good planning, organisational and presentation skills. *Performance measurement skills, *Excellent Communication skills (verbal, written, influencing, conflict management, presentation) and interpersonal skills. *Research and investigation, Analytical and report writing skills; Computer skills. *Resilience and ethical behaviour. *Must be willing to travel and work irregular hours. *A valid driver’s licence. Experience in and knowledge of health products regulation. A good understanding of the pharmaceutical, complementary medicines and medical device industries. Familiarity with international best practices in health product regulation and understanding of how these would relate to the South African context. Excellent awareness of South Africa’s health policy. In-depth understanding and knowledge of all relevant legislation, including the Medicines and Related Substances Act and the Public Finance Management Act (PFMA). Proven track record in the development and implementation of technical and operational strategies. 

DUTIES: Strategic and Operational Leadership: Develop strategy, annual performance plan, operational plans, and budget for the Medical Device and Radiation Control Programme, aligned with organisational needs and optimal resource utilisation. Contribute as a member of the senior management team responsible for strategic and operational planning of the organisation in order to ensure the achievement of organisational objectives and meet the needs of all stakeholders. Develop and coordinate systems for managing all programme operations. 

Regulatory Oversight and Compliance: Direct regulation of medical devices (including In Vitro Diagnostics, medical and industrial radiation-emitting devices), radionuclides, and electronic generation of ionizing and non-ionizing radiation. Oversee preparation and endorsement of reports to technical and advisory committees per legal requirements and SAHPRA standard operating procedures (SOPs). Oversee development, implementation, and maintenance of regulations, guidelines, policies, and procedures aligned with international and national protocols and relevant legislations. Ensure accurate, timely statutory reporting; full adherence to SAHPRA policies, SOPs, Terms of Reference (ToRs), and manuals; and performance management against standards, identifying improvement opportunities. Establish surveillance mechanisms to detect, assess, and prevent adverse reactions to devices, radionuclides, and radiation sources. Oversee compliance with service level agreements for outsourced services (e.g., laboratories) to meet quality and delivery standards. 

Reporting and Communication: Prepare monthly, quarterly, and annual reports on programme work, including timeline monitoring. Oversee effective, timeous communication and consultation on issues related to medical devices (including in vitro diagnostics), radiation-emitting devices, radionuclides, and radiation generation. Share critical updates (e.g., strategy/legislative changes). 

Local and International Stakeholder Engagement: Liaise with both local and international regulators and stakeholders to ensure accurate information exchange and productive relationships. Ensure active South African health regulatory authority participation in the global arena. Build sustainable partnerships with public and private sectors to deliver SAHPRA programmes. 

Financial, People, and General Management: Oversee programme budget, implement cost-saving measures in line with PFMA and Treasury regulations, and handle general financial responsibilities. Lead, train, and develop the team to meet performance targets, boost efficiency, and align with organisational needs. Foster ethical conduct, integrity, and superior performance standards across the team. Undertake any additional duties assigned by the Chief Regulatory Officer or Chief Executive Officer. 

INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): 

·       Interested candidates who meet the above requirements should submit an application clearly indicating the title of the position and reference number. Applications must include a signed cover letter, a detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, and certified copies of the required qualifications (including matric). Only shortlisted candidates will be required to submit certified copies of qualifications and other relevant documents on or before the interview date, as communicated by 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) and the Employment Equity Act, 55 of 1998. 

·       SAHPRA intends to promote equity (race, gender, and disability) in line with the numeric targets in our Employment Equity plan. We are committed to this when recruiting internally and externally, with a policy to promote from within wherever possible. Preference will be given to suitably qualified individuals from previously disadvantaged groups. 

·       People with disabilities (should indicate their disability status), males (all races) and females (Coloured and White) will be given preference. 

·       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: https://www.sahpra.org.za/vacancies.

·       For enquiries: Please contact Mr Tshepo 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 01 September 2026