QA / RA Administrator

AREAS OF RESPONSIBILITY

CHANGE CONTROL MANAGEMENT
Managing the Group Change Management programs and databases in alignment with ISO 13485 requirements and ensuring deadlines are not missed
Schedule change meetings and ensure change initiation documents are available
Maintain Change Control Index and follow up on action completion
Collate change control action evidence and once all evidence available prepare change pack for implementation and approval
Trend KPI data and provide report timeously for Management Review

RECALLS, FIELD SAFETY ACTIONS AND ADVERSE EVENTS
Maintain Index for recalls, field safety actions and adverse events
Prepare draft notification reports for recalls, field safety actions and adverse events
Follow up on the status of recalls, field safety notifications and adverse events till closure report is prepared
Reconcile customer acknowledgments and follow up with respective personnel to ensure recalls are closed timeously
Prepare and provide reports and ensure SAHPRA timelines for reporting is adhered to
Trend KPI data and provide report timeously for Management Review

ASSISTANCE WITH SAHPRA, NRCS, RAD CON, ICASA APPLICATIONS
Support in processes where actions are assigned
Review Change control index per legal entity
Prepare SAHPRA Application packs for QA RA Manager Review and Submission
Maintain index for submissions
Trend KPI data and provide report timeously for Management Review

ASSISTANCE WITH EXPORT REGULATIONS AND ASSOCIATED PRODUCT REGISTERATIONS
Support with investigation of Export requirements
Support with product registrations associated with Export Markets
Sub-distributor evaluation and support on approval process
Trend KPI data and provide report timeously for Management Review
Maintain index for submissions and country requirements

MEDICAL DEVICE FILE
Managing the Group Medical Device File programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed for provision of documents
Follow up with allocated department Product Managers and Specialists for Product Dashboards and product lists
Trend KPI data and provide report timeously for Management Review

KPI DATA COLLECTION AND ANALYTICS
Follow up with all sites and departments on monthly KPI data metrics
Ensure data is provided as per approved KPI Metrics

DOCUMENT CONTROL (External)
Managing the Group Document Control programs and databases in alignment with ISO 13485 and Regulatory requirements and ensure deadlines are not missed
Manage document email address and Shared-Point
Maintain Document Index for internal documents and External documents
eQMS Document Controll