Qualifications
Matric with a Degree: Science/ Medical / Biological/ Technical

Experience required
Advanced Computer Skills (MS Office Word, Excel, Powerpoint, Teams] [Non-Negotiable]
2-5 Years working experience in the Medical Industry [Preferable]
Experience with data collection and trending
Experience with Quality Management Systems ISO 13485 or ISO 9001 or any other ISO standard (Preferred)
Experience with Regulatory Affairs and understanding of regulations (Preferred)
Experience with SAHPRA, NRCS, ICASA (Preferred)

KPI DATA COLLECTION AND ANALYTICS
Ensure data is provided as per approved KPI Metrics for sections under responsibility
Perform data analysis and trending remarks

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.
Review completed product dashboards and supporting documents.
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.
Provide reports and ensure SAHPRA timelines for reporting is adhered to.
Trend KPI data and provide report timeously for Management Review.

ASSISTANCE WITH SAHPRA 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

RAD CON, NRCS, ICASA LICENCE APPLICATIONS
Support in processes where actions are assigned.
Maintain index for submissions and generate folders for applications.
Prepare RAD CON Application packs as required for legal entities

GENERAL
Support with External Audits as per allocated actions.
Document Control
Reviewing and updating of Standard Operating Procedures and Quality Documents.
General administrative duties including archiving, filing, issue of Quality Documents
Training
Ensure assigned training is completed timeously.
Provide training on areas under responsibility.
Continuous Improvement
Individual Quality Improvement Projects are assigned on an annual basis are completed in a timeous manner.
Identify improvement areas in processes under responsibility Apply Now

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QA RA Administrator Medical Equipment - Midrand

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