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.

Organisation SAHPRA

Unit Clinical Evaluation Management (CEM)

Work arrangement On site

Location Pretoria

Position Manager: Clinical Post-Registration Evaluations

Ref No SAHPRA 34 of 2026/27

Salary R 1 010 600 – R 1 237 700.00 per annum (TOTAL COST TO COMPANY)

EE X 

Permanent X  

Fixed term Contract

Disability X

JOB PURPOSE

The role of the Manager for Clinical Post-Registration Evaluations is responsible for leading the Business Unit by enforcing compliance, develop and implement regulations, mitigate risks and protect public health among others.

RESPONSIBILITIES:

Operational Management:

 Manage the operations of the Business Unit with regards to the processes, inputs, targets, outputs and resourcing requirements.

 Offer technical advice and support to team members on a range of regulatory issues/requirement.

 Implement SAHPRA policies and procedures to identify and resolve complex issues and inconsistencies and make recommendations on initiatives.

 Lead processes for appeals lodged against regulatory decisions taken by the national regulator.

 Manage the development of regulations, regulatory processes and guidelines within the Business Unit.

 Perform quality assurance of processes and outputs to ensure compliance with legislative and regulatory requirements.

 Apply scientific principles, regulatory requirements, best practices and quality assurance and review applications where applicable.

 Conduct reviews and/or adjudicate peer-reviewed reports and provide technical decisions regarding applications.

 Manage and support Clinical Technical Advisory Committee.

 Responsible to capacitate various operations or work streams of the Business Unit with skilled staff.

 Allocate program or project resources in line with strategic direction.

 Identify and prioritise resources across various initiatives or operations.

 Develop and monitor the implementation of the annual operational plan and Business Unit plans.

 Ensure operations and processes of the Business Unit are aligned to the relevant legal frameworks, prescribed local and international Guidelines.

Stakeholder Management:

 Conduct consultation meetings with representatives from the orthodox medicines industry to advise on administrative and technical issues.

 Respond to external enquiries by industry, Business Units within SAHPRA and other external stakeholders.

 Participate in industry engagements and regulatory forums regionally and internationally (e.g. Zazibona, WHO, ICH Working Groups, IPRP, Continental initiatives).

Financial Management:

 Develop or support the development of the programme’s budget and manage its implementation.

 Work together with Finance Unit to develop and manage the Business Unit’s annual budget.

 Ensure the effective implementation, management, monitoring of the Business Unit’s budget, and mitigate and report on any variances.

 Prepare and submit accurate financial reports within the required timeframe.

 Ensure revenue information is collated and provided to the Finance office within the required timeframe.

 Manage and ensure effective utilisation of financial resources.

Governance, Risk and Compliance Management:

 Develop, review, update and implement policies related to Standard Operating Procedures and Guidelines.

 Adhere to SCM and PFMA aspects and other SAHPRA policies and procedures.

 Ensure process changes are processed through effective change control processes.

 Apply risk management in processes.

 Manage all relevant internal and external audits by responding to any non-conformances or audit findings that are raised and develop mitigation reports.

 Provide timely and accurate evidence and expert analysis to support the Legal Unit in addressing compliance issues and legal matters.

 Ensure deviations or non-conformances are recorded and responded to.

 Implementation of Quality Management Systems (QMS) Culture.

 Manage the development and continuous monitoring of the QMS in the Business Unit – processes, guidelines in alignment with best practices (i.e., National, Regional, Continental, international).

 Manage the development and review of internal policies, in collaboration with senior management. Ensure compliance with implementation of approved processes.

 Ensure training records on all processes are maintained.

 Compile Business Unit reports as required (monthly reports, internal reports, external reports).

 Identify risks for the Business Unit, develop mitigation plans and oversee the implementation of mitigation plans.

 Ensure readiness for internal and external audits by maintaining accurate records, documentation, and compliance with audit requirements.

People Management:

 Develop (i.e., training, coaching, mentoring) and manage (i.e., recruitment, retaining, onboarding, offboarding, daily operations) of Human Resources within the Business Unit.

 Foster a positive and collaborative team culture.

 Ensure maintenance of confidentiality, high ethical conduct, efficient, effective high-quality performance of staff members.

 Manage workstream, staff members’ compliance with organisational policies and procedures by performing regular performance assessments and implementation of individualized interventions where applicable and escalating further non-compliance to the relevant Senior Manager.

 Lead and oversee the work stream team through task delegation, leave administration and planning, and cultivating a cooperative work atmosphere.

 Workstream staff members' training needs are identified, training programs are planned, and professional development is promoted to advance the workstream team's expertise and ensure retraining is executed where applicable.

 Support and manage development of annual performance reports.

 Peer annual performance report and 360 reports.

 Manage employee relations (Labour relations and wellness matters) within the Business Unit.

REQUIREMENTS

 A Matric or Grade 12 certificate and a four-year Bachelor of Pharmacy degree at NQF Level 8 and current registration with the South African Pharmacy Council, or an MBChB degree and registration as a Medical Officer with the Health Professions Council of South Africa (HPCSA) as recognised by the South African Qualifications Authority (SAQA).

 A post-graduate qualification in health sciences at NQF level 9 will be an added advantage.

 A minimum of ten (10) years’ relevant experience in medicines regulatory field in evaluation/compiling safety, quality and efficacy data, including product information and patient information leaflets. At least five (5) years must have been at a supervisory / management level (Level 09 – 12) supporting business operations.

 Experience in medicine registration will be an added advantage.

 Experience in the application of the Medicines and Related Substances Control Act 101 of 1965 (as amended), and its related Regulations.

 A valid driver’s licence.

COMPETENCIES AND SKILLS

 Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965), as amended, and its related Regulations and Guidelines.

 Knowledge of technical aspects for the evaluation of quality, safety, and efficacy of medicines.

Knowledge of Regulatory framework, policies, and process. Knowledge and understanding of clinical pharmacology.

 Understanding of medicine registration and harmonised standards.

 Knowledge of Good Clinical Practice.

 Organisational awareness.

 Principles of quality management.

 Performance and team management.

 Critical and analytical thinking.

 Projects management and leadership.

 Ability to manage a variety of cross-functional team members.

 Report writing.

 Communication skills (verbal, written, negotiation, conflict management, presentation).

 Risk based decision and Evidence-informed practice.

 Planning and organising.

 Change management.

 Problem analysis and solving.

 Interpersonal skills and team player.

 Integrity and flexibility.

 Attention to detail and results driven.

 Resilience and ethical behaviour.

Due to large number of applications 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.

 Interested candidates who meet the above requirements should submit their applications, clearly indicating the title of the position and the 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.

 The above-mentioned documents are compulsory. 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.

 When applying for a position on the Recruitment Portal, kindly ensure that your documents are grouped and uploaded as follows:

·       Cover Letter and CV combined into one document.

·       Qualifications/Certificates and ID Copy combined into one document.

 Shortlisted candidates will be expected to attend selection interviews on a specific date, time, and location as communicated by SAHPRA.

 Applicants should note that pre-suitability checks will be conducted after they have been shortlisted. The appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks (where applicable), citizenship status, employment verification and work experience.

 SAHPRA reserves the right not to appoint any candidate to the advertised post.

 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.

Employment Equity statement:

 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.

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

Application closing date: 02 October 2026

 Applications should be submitted through the SAHPRA Website Online Portal: http://www.sahpra.org.za/vacancies.

NOTE: SAHPRA WILL NOT ACCEPT APPLICATIONS SENT THROUGH EMAIL ADDRESSES.

Enquiries

Name Ms Bafedile Rakgotho, HR Business Partner

Email/ Tel No Bafedile.Rakgotho@sahpra.org.za/ 012 015 5405

RE-ADVERTISEMENT

EXPRESSION OF INTEREST Independent Expert Review of South Africa’s Draft Medical Devices Regulations 

Issued by: South African Health Products Regulatory Authority (SAHPRA) 

CALL FOR EXPRESSIONS OF INTEREST FROM MEDICAL DEVICES REGULATORY EXPERTS 

The South African Health Products Regulatory Authority (SAHPRA) is South Africa’s national regulatory authority responsible for the regulation of health products, including medicines, medical devices, In Vitro Diagnostic (IVDs)medical devices, radiation-emitting products and related health technologies, with a mandate to ensure access to safe, effective and quality health products. 

SAHPRA invites suitably qualified medical devices regulatory experts to submit an Expression of Interest to conduct an independent expert review of South Africa’s revised draft Medical Devices Regulations. 

This Expression of Interest is targeted at individuals with demonstrable expertise in medical devices regulation, particularly those affiliated with, or who have contributed to, the International Medical Device Regulators Forum (IMDRF), the African Medical Devices Regulatory Forum (AMDRF), or who are currently or previously employed by regulatory authorities responsible for the oversight of medical devices and in vitro diagnostic medical devices. The purpose of this process is to identify and appoint an independent expert or panel of experts who can provide an objective assessment of the draft regulations prior to their finalisation and implementation. 

BACKGROUND

South Africa has revised its Medical Devices Regulations under section 35 of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965). The revised regulations are intended to replace the current Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices published in Government Gazette No. 40480 of 9 December 2016. The draft regulations have undergone public consultation, including consideration of comments from industry, professional associations, public health stakeholders and other interested parties. The final regulatory package has also been supported by a Socio-Economic Impact Assessment (SEIAS) sign-off process. 

PURPOSE OF THE ASSIGNMENT 

The appointed expert will be required to provide an independent written review of the revised draft Medical Devices Regulations, and assess whether the regulations are globally aligned, contextually appropriate for Africa and South Africa, and capable of enabling a safe, competitive and sustainable South African medical devices industry. 

SCOPE OF THE INDEPENDENT REVIEW 

1.     Global alignment: assess the extent to which the draft regulations align with IMDRF principles and related international good regulatory practices, including risk-based classification, essential principles of safety and performance, conformity assessment, vigilance, reliance, clinical evidence, software as a medical device, post-market surveillance and quality management systems. 

2.     Regulatory reliance and convergence: comment on whether the regulations create sufficient enabling provisions for reliance on trusted regulatory authorities, recognised conformity assessment bodies, WHO Prequalification, Medical Device Single Audit Program (MDSAP) /ISO 13485 evidence and internationally accepted technical documentation, while preserving SAHPRA’s sovereign decision-making authority. 

3.     Relevance to the African context: assess the appropriateness of regulations for implementation in an African regulatory environment, including regional harmonisation, alignment with AMDF and African Medicines Regulatory Harmonisation (AMRH) objectives, scarce regulatory capacity, cross-border trade, public sector procurement realities and access to essential diagnostics and medical technologies. 

4.     Relevance to the South African context: review whether the regulations adequately address South Africa’s health system realities, including public and private sector use, rural access constraints, digital access limitations, post-market vigilance, importation routes, local accountability, use of local authorised representatives, and the need for traceability and patient protection. 

5.     Impact on industry enablement: assess whether the regulations are likely to enable or constrain the South African medical devices industry, including local manufacturers, importers, distributors, wholesalers, service providers, diagnostic laboratories and innovators, and whether they support competitiveness, investment, innovation and regional export potential. 

6.     Implementation feasibility: provide an opinion on whether the requirements are proportionate and practically implementable, particularly in relation to product registration, call-up notices, transitional arrangements, labelling, instructions for use, electronic information, ISO 13485 certification, conformity assessment body recognition, timelines and regulatory capacity. 

7.     Key risks and unintended consequences: identify any provisions that may unintentionally restrict access to medical technologies, increase regulatory burden without commensurate public health benefit, create ambiguity in supply-chain responsibilities, duplicate international controls, or impede South Africa’s role as a regional medical devices hub. 

8.     Recommendations: provide concrete recommendations on amendments, clarifications, guidance documents, transitional mechanisms or implementation sequencing that would strengthen the regulations prior to their finalisation. 

ELIGIBILITY CRITERIA 

Respondents should meet one or more of the following criteria: 

·       demonstrated expertise in medical devices and/or in vitro diagnostic medical devices regulation; 

·       current or previous affiliation with IMDRF, AMDRF, or related international or regional medical devices regulatory harmonisation initiatives; 

·       current or previous employment by a regulatory authority responsible for the regulation of medical devices or in vitro diagnostic medical devices; 

·       experience in regulatory reliance, convergence, conformity assessment, classification, clinical evidence, vigilance, post-market surveillance, quality management systems, or software as a medical device; 

·       understanding of regulatory implementation in low- and middle-income country contexts, preferably including African regulatory systems; and 

·       ability to provide an independent, evidence-based and practical written assessment within the agreed timeframe. 

DOCUMENTS TO BE MADE AVAILABLE 

For purposes of the review, SAHPRA will provide the revised draft Medical Devices Regulations, the consolidated responses to public comments, and the SEIAS sign-off documentation. These documents reflect the policy intent, stakeholder concerns and regulatory rationale underlying the current draft. 

EXPECTED DELIVERABLES 

We would appreciate a written independent review report that includes an executive summary, a high-level assessment of the overall regulatory approach, clause-specific or thematic comments where necessary, a view on readiness for implementation, and clear recommendations for strengthening global alignment and local applicability. Where appropriate, the report may distinguish between matters that should be addressed in the regulations themselves and matters that could be addressed through guidelines, transitional plans, implementation notices or operational procedures. 

SUBMISSION REQUIREMENTS 

Interested experts are invited to submit an Expression of Interest containing the following information: a brief motivation indicating suitability for the assignment; a curriculum vitae; details of relevant regulatory experience; a declaration of current or previous affiliation with IMDRF, AMDRF or a medical devices regulatory authority; confirmation of independence and absence of conflict of interest; availability to complete the assignment within four to six weeks from receipt of the full document pack; and an indication of proposed fees or remuneration expectations, where applicable. 

EVALUATION OF EXPRESSIONS OF INTEREST 

Expressions of Interest will be considered based on relevant medical devices regulatory expertise, demonstrated international or regional regulatory experience, familiarity with IMDRF and/or AMDF principles, understanding of African and South African public health and regulatory contexts, independence, availability, and ability to produce a clear and practical expert report. 

INDEPENDENCE AND CONFIDENTIALITY 

The review will be an independent expert assessment and should not be construed as an endorsement by IMDRF, AMDF or any regulatory authority unless formally authorised through the appropriate institutional processes. SAHPRA will treat the findings as expert advisory input to support evidence-informed regulatory decision-making. Any non-public documentation shared for purposes of the review must be treated as confidential and used only for the agreed purpose. 

PROCEDURE

·       This is a re-advertisement, candidates who previously applied need not to re-apply.

·       Expressions of Interest must be submitted online at https://apply.sahpra.org.za:6006

·       Only documents in pdf must be uploaded. 

·       Further communication will be limited to nominated candidates with appropriate skill sets.

·       Closing date for nominations is Friday, 25 September 2026 at 16h30. No late submissions will be accepted. 

Enquiries: Office of the CEO at CEOOffice@sahpra.org.za