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You would be working in pre-market for the surgical care business unit mainly remote working, but you are required to go onto the Winsford site intermittent. You will be collaborating with a variety of departments both internally and externally to ensure all regulatory reports and documentation is compliant with relevant requirements. As a Regulatory Affairs Associate some of your key responsibilities include:
As the ideal candidate, you will have a degree or equivalent, in a Life Science, or similar industry experience. Knowledge and understand of FDA Quality System Regulation and ISO 13485, relevant GMP and European Medical Devices Regulation (MDR). You will be analytical, able to work under pressure and have excellent communication skills both written and verbal. Having experience maintaining technical files and working within a regulated industry is essential.