QUALITY ASSURANCE AND REGULATORY AFFAIRS ASSISTANT

The successful candidate must have:

• Relevant qualification in line with the job opportunity;
• At least 1-year experience in Quality and Regulatory Affairs;
• Experience in medical device industry;
• Exposure to medical device regulations in African countries as well as knowledge of the current South African regulations for medical devices;
• Exposure and knowledge of ISO 13485:2016 implementation and upkeep;
• Computer literate with prior experience with MS Office, PowerPoint and Excel.

The Core responsibilities will be:

• Ensure company compliance with QARA principles related to all medical devices in the SADC region including GMP, SOP’s, audits training and customer complaints;
• Initiate, populate and manage Non Conformances /CPAR register with new NCR/CPARs and follow up on outstanding/CPARs;
• Provide monthly updates to the QARA Manager on the outstanding NCR/CPARs;
• Follow-up and ensure the closing off of CPARs;
• Ensure legal compliance with the relevant Regulatory Authorities (Country Specific), and ensuring timeous processing of regulatory applications;
• Audits internal and external (conduct and assist);
• On-going QARA review and monitoring of compliance against established key performance indicators;
• Ensure ISO13485:2016 implementation, certification and upkeep;
• Support medical device registration and life cycle management activities for the organization’s medical devices with the relevant authorities;
• Maintaining the technical file documentation in compliance with SAHPRA requirements;
• Develop and support implementation and maintenance of regulatory and QA processes for medical devices;
• Develop internal SOP for regulatory and QA guidance and regulations;
• Contribute to and participate in internal and external education and training activities Identify and communicate relevant guidance, policies, standards, and regulations;
• Build and maintain effective relationships with internal and external stakeholders;
• Support regulatory compliance initiatives;
• Establish evacuation plan and perform regular fire and evacuation drills (company and site);
• Ensure Compliance with applicable H&S Standards;
• Conduct regular audits, including risk assessment survey where required;
• Hold regular OHS site meetings, and minute such meetings;
• Maintain necessary and applicable registers;

Core Competencies:

• Knowledge of the Regulatory requirements for medical devices in South Africa;
• Ability to prioritise and work to tight deadlines;
• Systems approach;
• Cross Functional skills: Ability to network, liaise and negotiate with others;
• Ability to set standard and objectives and monitor progress;
• Problem solving and decision-making skills;
• Excellent communication skills;
• Self-motivated;
• Good time management skills;