Quality and Regulatory Officer - Pretoria at Arjo

Essential Duties and Responsibilities:

• Execute and assist in the design implementation, maintenance and certification of Quality Management policies and procedures to meet the requirements of ISO9001, ISO13485 and/or as directed by management.
• Ensure Global Management system SOP and associated documents are embedded in local system and distributed to relevant or affected management and staff.
• Integrate requirements of SOP124 into the QMS and ensure on going compliance.
• Monitor publication of Global Management system SOP and associated documents.
• Assist with ensuring Management and staff are trained and fully understand their role in the quality management systems, Global Management system SOP and associated documents
• Assist with ensuring training records for all staff effected by the quality system are kept and maintained.
• Efficiently manage non-conformances within the business.
• Maintain good document & data control.
• Assist in conducting internal quality audits, supplier quality audits as required,
• And Distributor audits as required
• Assist and support with regulatory and compliance activities and requirement for the region
• Ensure all components and activities linked to trackwise is executed timeously and effectively as per the local and global standards
• Ensure all Post Market Activities such as incident reports, field actions, are executed timeously and efficiently with all internal and external stakeholders
• Monitor projects to maximise the probability for project objectives, success criteria, quality and time frames to be achieved.
• Maintain strong business relationships with existing customers by ensuring compliance with all contract requirements, obtaining feedback and maintaining quality work.

Requirements:

• 3+ years experience in Africa Regulatory Affairs for Medical Devices.
• High knowledge of Quality and Regulatory systems.
• Be knowledgeable of current risk management standards, principles and frameworks.
• Reviewing and completing activities according to previously defined priorities.
• Demonstrated expertise with Microsoft Windows operating system and MS Office applications.
• Experience in Health Care and/or Medical Devices industries.