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health.gov.za Deputy Director : National Department

Company Name : National Department Of Health
Job Title : Deputy Director
Department : Medicine Control
Closing Date : 31 October 2016
Location : Pretoria
Ref No: NDOH 117/2016
Employment Type : Grade 1
Salary : R772 110 per annum.

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Website : https://www.health.gov.za/vacancies/
Notification : https://www.southafricain.com/uploads/2427-dep-director.pdf

Deputy Director – Medicine Control :

Requirements :
** A Degree in pharmacy and registered as a pharmacist
** A post graduate degree will be an advantage

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Related : Newcastle Municipality Municipal Manager : www.southafricain.com/2424.html

** 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.

Duties :
** 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 of Chairperson of the MCC.

Enquiries : Dr J Gouws at tel no (012) 3958003

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