The Department of Health is registered with the Department of Labour as a designated Employer and the filling of the following posts will be in line with the Employment Equity Act (including people with disabilities).
Deputy Director: Medical Devices
Reference no: NDOH 117/2016
Note: This is a re-advertisement. Applicants who have previously applied need not re-apply.
Salary: Grade 1: R772 110 per annum.
Centre: Chief Directorate: Food Control, Pharmaceutical Trade and Product Regulation. Pretoria.
- A Degree in pharmacy and registered as a pharmacist
- A post graduate degree will be an advantage
- At least five (5) years proven regulatory experience in the Pharmaceutical Industry and/or Medical Device Industry in relation to the regulatory compilation of medicine or medical device at junior management or equivalent level
- Knowledge of the Medicines and Related Substances Act (101 of 1965), as amended; and the General Regulations pertaining to the control of medical devices (IVDs and Non IVDs)
- Knowledge of regulatory scientific and technical requirements as well as knowledge of the administrative processes of medical devices (IVDs and Non IVDs) and the licensing of medical devices establishment in RSA
- Familiarity with ISO13485 and International Devices Regulatory Forum (IMDRF) standards and quality assurance principles relating to medical devices and IVDs
- Knowledge of the Public Finance Management Act (PFMA) and Quality Management Systems and implementation thereof
- Good communication (written and verbal), planning, organisation, co-ordination, project, diversity management, leadership, facilitation and statistical analysis skills
- Ability to work in a highly pressured environment and driven by a sense of urgency to meet deadlines
- Must be willing to travel and work irregular hours
- A valid driver’s license.
- Develop, implement and maintain a Medical Device regulatory system for the regulatory oversight, including the registration of IVDs and Non IVDs and licensing of medical device establishments
- Supervise human resources/staff and oversees the day to day functioning of the component
- Support the Medicines Control Council and the Expert Medical Device Committee
- Oversee the use of unregistered medical devices for purposes of conducting a clinical trial or patient specific compassionate use
- Implement a Quality Management System within the Medical Device Directorate to support the activities of the directorate
- Attend to media enquiries, parliamentary questions, or any enquiries on matters relating to the regulatory oversight of Medical Devices as directed by the Registrar or Chairperson of the MCC.
Enquiries: Dr J Gouws at tel no (012) 395 8003
Closing date: 14 November 2016
Applications: The Director-General, National Department of Health,Private Bag X828, Pretoria. 0001. Hand delivered applications may be submitted at Reception (Brown application Box), Civitas Building, corner of Thabo Sehume (formerly known as Andries) and Struben streets.Pretoria.
For attention: Ms N Sombinge
Originally certified certificates of service must be submitted with your application
Applications should be submitted on form Z83 obtainable from any Public Service Department and should be accompanied by a CV (previous experience must be comprehensively detailed) and certified copies of qualification certificates(including Senior Certificate/Grade 12 certificate regardless of the qualification requirement indicated in the advert), service certificates, including ID and driver’s license. No faxed or e-mailed applications will be considered. Applications received after the closing date and those that do not comply with the requirements will not be considered. It is the applicant’s responsibility to have foreign qualifications and national certificates (where applicable) evaluated by the South African Qualification Authority (SAQA). The department reserves the right not to fill the post. The successful candidate will be subjected to personnel suitability checks and other vetting procedures. Applicants are respectfully informed that correspondence will be limited to short-listed candidates only. If notification of an interview is not received within three (3) months after the closing date, candidates may regard their application as unsuccessful.
The Department will not be liable where applicants use incorrect/no reference number(s) on their applications.