TECHNICAL OFFICER

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, clinical trials and medical devices, and related matters in the public interest.

TECHNICAL OFFICER: LICENSING & VIGILANCE
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience
obtained post qualification and community service.
Ref No.: SAHPRA 079/2023

CENTRE: PRETORIA

REQUIREMENTS: Matric certificate and a 4-year degree in Pharmacy or Honours
Degree in Medical Sciences /Clinical engineering or related equivalent at an equivalent
NQF level 8 as recognised by SAQA. Registration with the relevant body. A relevant
Master’s qualification will be an added advantage.

Grade 1 – 4-year degree in Pharmacy or Honours Degree in Medical Sciences /Clinical
engineering or related equivalent at an equivalent NQF level 8 as recognised by SAQA.
Registration with the relevant body. Minimum three (3) years’ experience of which two (2)
years’ must be regulatory in Medical Devices and IVDs. Working knowledge and/or
understanding of Medical Devices Licencing, Vigilance and Post Marketing Surveillance
requirements.

Grade 2 – 4-year degree in Pharmacy or Honours Degree in Medical Sciences /Clinical
engineering or related equivalent at an equivalent NQF level 8 as recognised by SAQA.
Registration with the relevant body. Minimum eight (8) years’ experience of which five (5)
years’ must be regulatory in Medical Devices and IVDs. Working knowledge and/or
understanding of Medical Devices Licencing, Vigilance and Post Marketing Surveillance
requirements plus a Master’s qualification will be an added advantage.

CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: Comprehensive
knowledge and understanding of relevant legislation, Medicine and Related Substances Act
101 of 1965, 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 organization 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.
Valid Driver’s License. Ethical behaviour and adherence to the SAHPRA Code of Conduct. At
SAHPRA we adhere to our core values: Ubuntu, Responsiveness, Integrity, Transparency,
Efficiency, 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 Licencing 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 device 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 weekly work-plan and output to the Unit manager (quantitative and qualitative reports).
Perform other functions that may arise from time to time.

INSTRUCTIONS TO APPLICANTS: All applications must:

• Be submitted with a covering letter clearly reflecting the name of the position and post
  reference number, be signed, accompanied by a comprehensive CV, the names and
  email addresses of 3 referees and recently certified copies of ID, required qualification/s
  (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered.
  Should you be in possession of a foreign qualification, it must be accompanied by an
  evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable
  where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are
  received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received
  a response from SAHPRA within 3 months of the closing date, please consider your
  application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time
  and place as determined by SAHPRA.

Applicants must note that further checks will be conducted once they are shortlisted and that
their appointment is subject to positive outcomes on these checks, which include security
clearance, qualification verification, criminal records, credit records, citizenship status and
previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are
encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves
the right to fill or not to fill the vacant post/s.

Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND
APPLICATIONS TO THIS EMAIL ADDRESS).

CLOSING DATE: The closing date is the 12 January 2024 at 16H00.

Click here to apply

All the best with your applications