and other designated markets. This role involves managing regulatory submissions, writing and reviewing Authority (SAHPRA) and other relevant authorities. Manage timelines for regulatory submissions and approvals regulatory submissions. 5. Documentation and Records Management: Maintain regulatory documentation and records readily accessible. Implement and manage electronic document management systems (EDMS) for regulatory submissions Docubridge or a similar electronic submission management system will be an advantage. Skills and Competencies:
and other designated markets. This role involves managing regulatory submissions, writing and reviewing Authority (SAHPRA) and other relevant authorities. Manage timelines for regulatory submissions and approvals regulatory submissions. 5. Documentation and Records Management: Maintain regulatory documentation and records readily accessible. Implement and manage electronic document management systems (EDMS) for regulatory submissions Docubridge or a similar electronic submission management system will be an advantage. Skills and Competencies:
applications etc. Reviewing daily sales report to manage future-dated deliveries. Making IBT requests as Sales Manager as required. Reviewing weekly call-off report in conjunction with Sales Manager to manage Competent computer skills. Organised, able to manage own time. Good command of the English language
applications etc. Reviewing daily sales report to manage future-dated deliveries. Making IBT requests as Sales Manager as required. Reviewing weekly call-off report in conjunction with Sales Manager to manage Competent computer skills. Organised, able to manage own time. Good command of the English language
analysis and trending remarks. MEDICAL DEVICE FILE Managing the Group Medical Device File programmes and databases documents. Follow up with allocated department Product Managers and Specialists for Product Dashboards and product Trend KPI data and provide report timeously for Management Review. RECALLS, FIELD SAFETY ACTIONS AND ADVERSE Trend KPI data and provide report timeously for Management Review. ASSISTANCE WITH SAHPRA APPLICATIONS Support entity. Prepare SAHPRA Application packs for QA RA Manager Review and Submission. Maintain index for submissions
analysis and trending remarks. MEDICAL DEVICE FILE Managing the Group Medical Device File programmes and databases documents. Follow up with allocated department Product Managers and Specialists for Product Dashboards and product Trend KPI data and provide report timeously for Management Review. RECALLS, FIELD SAFETY ACTIONS AND ADVERSE Trend KPI data and provide report timeously for Management Review. ASSISTANCE WITH SAHPRA APPLICATIONS Support entity. Prepare SAHPRA Application packs for QA RA Manager Review and Submission. Maintain index for submissions