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SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) - MANAGER: RADIATION CONTROL
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, 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.
MANAGER: RADIATION CONTROL
Ref No.: SAHPRA 056/2020
CENTRE: Cape Town/Pretoria
REQUIREMENTS: * B.Sc. Degree with Honours in Medical Physics. * Professional registration with the HPCSA.
Experience: 10 years’ experience in any combination of the three fields, including radiation oncology, nuclear medicine and diagnostic radiology as a minimum requirement. * Minimum 8-years of managerial experience. * Knowledge of and experience with relevant national legislation, international standards and best practices, e.g., IAEA requirements.
COMPETENCIES/SKILLS: * Advanced knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. * Management of operational plans, business plans and budgeting. * Performance management and team management skills. * Self-motivated and ability to work independently. * Ability to manage a variety of cross-functional team members. * Competent in problem solving, research skills and team building. * Attention to detail. * Information evaluation. * Decision making. * Objectivity. * Resilience and ethical behaviour. * Communication skills (verbal, written, negotiation, conflict management, presentation). * Interpersonal skills. * Assertiveness. * Customer/Licensee service. * Planning and organising skills * Flexibility. *A valid driver’s licence.
DUTIES:
• Manages and controls the operations, processes, and innovations of the Radiation Control Unit: * Develops and co-ordinates systems for management of all operations of the Radiation Control Unit. * Manages the regulation of ionising and non-ionising radiation sources. * Manages the development, implementation and maintenance of regulations, guidelines, policies and procedures pertaining to regulation of ionising and non-ionising radiation sources, to ensure alignment with international and national protocols, legislations and other legal requirements. * Prepare monthly, quarterly and annual reports for work done within the Radiation Control Unit including monitoring of the timelines. * Preparation of reports to be submitted to relevant technical committee for their information, discussion, review and/or recommendation to the relevant advisory committee in accordance with prescribed legal requirements and standard operating procedures of SAHPRA. * Manages surveillance mechanisms to detect, assess and prevent adverse reactions related to ionising and non-ionising radiation. * Representing the South African Health Products Regulatory Authority in the global arena through active and meaningful participation. * Managing relationships and agreements, such as memoranda of understanding with international partners where relevant. * Managing compliance to service level agreements with outsourced support services to ensure achievement of agreed quality and delivery standards. * Manages general financial budgeting, human resources and performance of the Radiation Control Unit. * Performing such other functions as the Senior Manager: Medical Devices & Radiation Control may duly allocate or delegate from time to time.
• Ensures effectiveness of Radiation Control Unit operational processes: * Develops operational plans and budget for the Radiation Control Unit aligned with organisational needs and ensuring the most effective utilisation of resources. * Manages, reviews and optimises operations and processes. * Manages, develops, reviews, and improves the accuracy of databases. * Manages operations, processes, and projects between the four sub-units. * Manages effective utilisation of resources to enhance value for money. * Develops (and reviews) internal policies, in collaboration with senior management. * Evaluates and improves security (physical, information, cyber).
• Manages the appropriate development, evaluation, and continuous improvement of regulatory control by: * Advising on and leading processes to improve regulatory control and cooperative governance. * Managing research projects and new developments in these fields. * Managing international, regional and national technical cooperation projects. * Managing regulatory systems for radiation control. * Identifying gaps, overlaps and shortcomings in the regulatory control and cooperative governance processes. * Maintaining confidentiality and ethical behaviour.
• Builds human capital in the Radiation Control Unit by: * Training and managing the deputy manager reporting to this role to ensure they have the skills required by the organisation and can achieve their performance objectives. * Working with Senior Manager: Medical Devices & Radiation Control and relevant functional heads to develop plans and procedures for information and knowledge management and the sourcing, acquisition, and development of staff with required critical skills. * Ensuring that a high level of integrity is maintained by staff members by promotion of high ethical conduct and maintenance of high-performance standards.
• Implements internal communication and incident reporting procedures by: * Managing the effective, timeous communication and consulting thereon regarding issues relating to ionising and non-ionising radiation sources. * Liaising with representatives from industry and international regulators, and other relevant stakeholders to ensure appropriate and correct information and establishment of productive and relevant relationships. * Liaising with senior management and the legal and communications departments for advice and to clarify established SAHPRA systems and methodologies. * Providing comments, inputs and advice on international standards and guidance documents, representing the interests of South Africa as member state of the IAEA, under the guidance of senior radiation scientists and senior management. * Managing investigation of incidents and accidents, and the formulation of appropriate communications with licensees, other regulatory authorities, and general public, in collaboration with the Deputy Managers and under the guidance of the Senior Manager: Medical Devices & Radiation Control. * Representing SAHPRA interests on international, regional and national levels (forums, committees, etc.). * Maintaining confidentiality and ethical behaviour.
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 of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the afore mentioned 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.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date and time, 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: 19 February 2021 at 16H00.