- Posted 18 January 2024
- Job type Permanent
- Contact NameRebecca Wallis
I am working with a leading Biotech and Medical device organisation on their search for a Production Compliance Engineer based in Oxfordshire.
You will join a dynamic Production Engineering team and take ownership of ensuring regulatory compliance for the companies innovative products and devices and manage global market access projects for both new and existing products.
You will be responsible for:
- Taking responsibility for overseeing compliance for all devices.
- Acting as the lead representative for design change assessment projects.
- Producing, managing, and maintaining regulatory documentation, including product technical files and risk assessments.
- Providing technical and regulatory requirements to the design and development process.
- Take responsibility and manage global market access activities for both new and existing products.
- Monitoring and managing changes in regulations, directives, and standards.
- Coordinating third-party testing and consultants.
You will bring the following:
- Experience thorough understanding of testing and liaising with test houses for IEC61010 and EN61326 standards
- Expertise in managing Global Market Access (GMA) pro