| * BSc degree with relevant administration experience. ISO 13485 certification. 5 month fixed term contract.* |
| Location: |
Midrand |
| Description: |
A company in the medical device industry requires an Office Administrator to join them for a fixed term contract. Key duties will include: Preparation of regulatory documentation to ensure compliance with medical device regulations, as well as collate the necessary documentation for product market authorization. Implement where needed and maintain ISO 13485:2016 documentation in ISO QMS File. Assist with product registration for SAHPRA and compiling of STED / Technical files on all Medical Devices and IVD’s. Establishing and maintaining a regulatory authorisation database. Compilation of technical dossiers and product files for CE-Marked products. Compilation/filing of MSDS and all product related essential documentation including technical documentation. Filing and keeping records of Certificates of Analysis and Certificates of Origin. Compilation of product risk analysis. Attend compliance meetings and regulatory forums and relaying the information to everyone at the company. Compiling and submitting of tender documents both online and hard copies. Keep copies of SAHPRA Guidelines and Regulations and implement or update as required by regulations. Work with Engineers to keep services records, supplying of quotations for services, ensuring services are carried out and documents thereof being filed. Keeping an up-to-date record of equipment spares alongside the Office Manager. Ordering spares and parts from suppliers. Train staff on all updates to regulations and ISO 13485:2016. Compiling NCR reports and incident reports. Conducting Management Reviews alongside the Director. Conducting Internal Audits. Assisting with External Audits. Discarding of expired stock and recording of non-conforming products. Compiling NRCS submissions with consultant. Assist with general administration such as quoting, invoicing, ordering, printing out delivery notes, writing out waybills, assist with stock controlling. Ensure that the Quality Management System documentation is kept up to date. |
| Key Requirements: |
BSc degree with relevant administration experience. Relevant industry experience will be advantageous. ISO 13485:2016 certification essential. This is a 5 month fixed term contract. |
| Additional Requirements: |
Hands-on person who is willing to help where and when necessary. Attention to detail is critical in this position. Strong oral and written communication skills. |
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| *Only candidates that meet all the requirements should apply |
| **Please quote “Office Administrator (G883)” in the subject line |
| ***Only candidates that are shortlisted will be contacted |
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