Regulatory Affairs Senior Associae
An independent diabetes medical devices organisation are currently recruiting for a Regulatory Affairs Senior Associate to join their team based in South Wales. This role focuses on technical file management, verification and validation coordination, device registration and reimbursement. This role will give you the opportunity to review standards and requirements to ensure these are fulfilled through design and write technical documentation to support regulatory filings. You will also gain experience with other organisational departments serving as a regulatory representative on cross functional teams. This position includes the potential for European travel. You will benefit from working as part of an organisation which has excellent growth potential and encourages its employees to be innovative, original thinkers, and collaborators to drive towards results. This will enable you to contribute to new ideas and improve the way things are done, meaning you can make a real difference. To apply for this role you will need: A medical engineering or suitable technical/ scientific qualification or relevant medical device regulatory affairs experience Knowledge of relevant international standards, regulations and guidelines (EU Directives, MEDDEV guidelines, FDA 510(k), ISO 13485) Language: English and French The opportunity to work with this fast growing medical devices organisation would provide a highly competitive salary plus benefits including private healthcare, flexible working, excellent pension scheme and much more. If you believe you have the experience and capabilities to fulfil this Regulatory Affairs Senior Associate role then please reply immediately or call Claire on . Sthree UK is acting as an Employment Agency in relation to this vacancy.