Main responsibilities will include:

• Maintain the Quality Management System (QMS) and certification in accordance with ISO 13485:2016 and SAHPRA requirements.
• Ensure established processes in Africa sites are complying and in alignment with company Corporate and Regional Policies and Procedures.
• Ensure post market compliance (adverse events and field actions/recalls) and reporting to national competent authorities according to local regulations which apply to country activities, business needs and marketed products and services.
• Manage company Africa Suppliers, 3PL and Channel Partners (onboarding, performance evaluation, audits)
• Manage Internal, Corporate and External audits.
• Manage CAPA, quality plans and quality management review with LT (Leadership team)
• Fulfils the role of a Quality Management Representative for BD South Africa and other African Hub countries (excluding North Africa) in ensuring that executive management is informed of quality related matters impacting customers or identified potential risks so that appropriate actions are taken.

About you

• Scientific degree in a related field.
• Experience in quality or regulatory affairs roles in medical devices industry
• Knowledge/Experience with SAHPRA and other African Competent Authorities post market regulation and post market compliance reporting requirements (Adverse Events and Field Actions/Recall)
• Quality Management System knowledge and auditor certified ISO 13485 (mandatory)
• Reasoning ability: able to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to read, analyze and interpret technical, quality and regulatory documents.
• Ability to effectively present information and respond to questions from groups of managers, clients and customers.
• Computer skills (MS-Office)