Quality Assurance / Regulatory affairs position available
An established medical device supplier is currently looking for a quality assurance officer to support the company to meet their quality and regulatory requirements.
The Quality assurance will provide direction and guidance to support the company in maintaining their regulatory compliance and quality systems.
Support the preparation and submission of all documentation to ensure that the products are compliant in all countries supplied into.
Reporting all Vigilance incidents, which could affect quality to the Regulatory Affairs/Quality Assurance in a timely fashion.
Ensure suppliers are set up on the system and that they complete all the relevant documentation. Provide clients with relevant compliance documentation where required
The ideal candidate will have a comprehensive knowledge of medical device quality standards and regulatory requirements.
Experience in the medical device industry, working to 13485 quality management systems and medical device directives and regulations
In exchange they will offer flexible working and a competitive salary