Walker Cole is looking for Regulatory Affairs Specialist to join an exciting fast-growing medical device company with international scope based in Northern Ireland. As a Regulatory Affairs Specialist you will be: Assisting in maintenance of technical files, including creation and control of documentation. Support transition from MDD to MDR where required. Liaise with departments to support Regulatory activities. Implement actions as directed by Regulatory Managers, including in support of Engineering Changes. Support teams during external and internal audits. Support in global registration activities. Work with technical documentation within electronic document management systems. A Regulatory Affairs Specialist will have: Experience within Medical Devices or a related area. Understanding of the Regulatory Profession. Teamwork and great oral and written communication skills. Experience working with Microsoft, Acrobat Pro. Desirable skills of a Regulatory Affairs Specialist: Experience of ISO13485 Understanding of 21 CFR p820, MDD and/or MDR Experience of document management and/or ERP systems. Regulatory Affairs // Specialist // MDD // MDR // Medical Device // ISO13485 // 21 CFR