Arjo's job vacancy, Career and Recruitment Job title : Quality and Regulatory Officer - Pretoria jobs in Gauteng Job Location : Gauteng, Pretoria Deadline : July 07, 2024 Quick Recommended Links
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.
*Production / Manufacturing jobs in south africa
*Quality and Regulatory Officer - Pretoria in Pretoria
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