Technical Officer: Medical Devices- Vigilance at South African Health Products Regulatory Authority

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 shortlisted 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
• 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.