JOB- Quality & Regulatory Affairs Manager LOCATION- Oxfordshire TERM- Permanent SALARY- £40,000- £50,000 per annum (dependent on experience) We are looking for a Quality & Regulatory Affairs Manager on a permanent basis within the Oxfordshire area.Considering making an application for this job? Check all the details in this job description, and then click on ‘apply’.The position can be up to 75% remote.The candidate must have 5 years or so experience in class 2b medical devices.The Quality & Regulatory Affairs Manager will ideally have the following attributes: Bachelors degree in Science, Engineering or related field Over 5 years experience with class II/III medical device regulatory affairs experience Experience of ISO 13485 & ISO14155 standards Experience of integrated eQMS Thorough understanding and experience of Regulatory documentation Experience of GMP, process validation, change control, CAPA and risk management Prior experience in medical device start up preferred Good leadership & project management skills, ability to effectively build and manage a high performing team Pragmatic and practical; can develop process and standards as well as manage a teamThe Quality & Regulatory Affairs Manager role will involve: Take ownership of all QA and RA functions leading to approvals and post market surveillance Develop, interpret and continuously improve efficient work flow based system in accordance to ISO13485 Create, implement and maintain a Design & Development plan Responsible for assisting in implementing regulatory requirements in accordance wit US regulations Ensure requirements are met internally and throughout the supply chain during manufacturing Manage Quality system audit processes Manage quality related activities for device manufacturing, implementing and maintaining controls (inspection standards, plans, frequencies and test methods) Provide company employee training in relevant areas of regulatory affairs and the quality system Monitor actions of Global regulatory agencies to stay current with requirements and changesIf you are interested in this position, please apply with an up to date CV to find out more, along with your availability and your salary expectation