Regulatory Affairs Coordinator, Medical Devices, Medical Device, Hampshire, Regulatory Affairs
This market leading organisation is a globally recognised specialist who develop and market surgical instruments used within the medical industry. Due to recent expansion they now have an exciting opportunity available for a Regulatory Affairs Coordinator to join their Quality Assurance team based in Andover, Hampshire.
As the Regulatory Affairs Coordinator you will be responsible for providing full coordination to support the Regulatory Affairs programme within the UK and Ireland, as required by the quality system requirements.
Other duties within this varied role will include:
-Working to ensure compliance with FDA, Quality System requirements, ISO 13485 and other regulatory affairs standards
-Ensuring that all manufactured products are compliant with relevant European and US FDA standards
-Maintaining up to date RA procedures
-Assisting with the regulatory approval of new and existing products
-Generating documentation to be submitted to regulatory authorities
-Managing the technical files
-Coordinating and maintaining literature approval processes
The successful candidate will have previous experience of working within a regulatory role to ISO 13485 and FDA Standards. Experience of working within the Medical Device industry is essential for this role. You will also have a strong background in working with quality management systems.
Within this varied role you will receive an attractive salary and benefits package, ongoing training and career progression opportunities.
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
