Technical Officer – Medical Devices Registration

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 five (5) years’ experience in a regulatory environment, of which three (3) years must be in regulation and/or registration of medical devices including in vitro diagnostic (IVDs), assessment of quality, safety, performance of medical devices and development and maintenance of standard operating procedures and technical guidelines. 

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

• Develop and maintain guidelines and standard operating procedures for medical device and IVD registration 
• Provide data for preparation product call-up document for publication
• Provide technical support for product registration of medical devices including IVDs according to the medicine and related substance Act 101 as amended
• Screen, evaluate and manage applications for registration of medical devices including IVDs and maintain relevant databases.
• Assist in developing and co- ordinating systems for management of all operations of the Medical Devices & IVDs Unit: Registration, Clinical Trials & Section 21
• Compile monthly, quarterly, and annual reports for work done within the Medical Devices & IVDs Unit: Registration, Clinical Trials & Section 21 including monitoring of the timelines
• Provide data and prepare reports, minutes and participate during medical device product registration meetings
• 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
• Engage members from industry to discuss SAHPRA Board resolutions, requirements of the Act and medical device including IVD quality issues
• Investigate and attend to industry/applicants’ queries
• Capture and maintain data relating to measuring and monitoring performance metrics and peer-reviewed reports, and record statistics generated
• Manage the associated risks, 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.