Do you have experience delivering in a Quality or Regulatory role within an organisation working to ISO 13485? I have an opportunity available to join a growing diagnostics company at their head office in Newcastle.
They have developed a point of care diagnostic device, to be used in remote locations with financial difficulties. The product has been recognised with multiple awards, including receiving investment from the Bill and Malinda Gates Foundation.
They are currently in the R&D phase and will be moving onto manufacturing in Q2 of 2020. This is an exciting time to join, with CE marking and FDA applications in the pipeline.
You will be working under the Regulatory and Quality Manager, supporting and leading on a variety of QA/RA activities, including:
- Technical file preparation and remediation
- Risk Management
- Design reviews and design control
- QMS maintenance and management
- Internal and external audits
- QMS and compliance training for other staff
As a Senior QA/RA officer you will be expected to arrive with existing knowledge of ISO 13485 and ISO 14971. Auditing and IVD experience would be useful but is not essential.