Comply Guru offer transformative training in the Life Sciences Industry. We are looking for suitable candidates for a fulltime role as a Regulatory Affairs Specialist. The ideal candidate will join a team of highly motivated, passionate people who are creatingindustry-leadinglearning solutions for a global audience.The Regulatory Affairs Specialist supports the QA/RA Director in ensuring Comply Guru's training programs, processes, and products meet applicable quality and regulatory requirements. This role focuses on maintaining up to date regulatory content, supporting accreditation activities, and contributing to the implementation and continual improvement of the company's Quality Management System (QMS).The ideal candidate is detail orientated, organized, and passionate about regulatory compliance, quality standards within MedTech and training.**This role requires work authorization in Ireland - only apply if authorized to work in Ireland**This role is a hybrid working position. High-speed internet connection essential.Key Responsibilities:Regulatory AffairsSupport maintenance and development of course content and training materials related to regulatory affairs (e.g., MDSAP, MDR, FDA, QSR/QMSR, ISO 13485)Research and monitor changes to relevant international regulations and standards; assist in updating training materials and internal documentation accordinglyPrepare regulatory documentation and evidence as required for audits, accreditation renewals, and partner reviews (CQI, IRCA, RAPS, Exemplar Global, or equivalent)Assist in maintaining Comply Guru's accreditation as an Approved Training Partner by ensuring compliance with relevant external bodiesSupport communication of key regulatory updates to the QA/RA Director and internal stakeholders.Quality Management System (QMS)Assist in implementing, maintaining, and improving the ISO 9001 based QMS to support certification and compliance objectivesMaintain controlled documents, records, and logs in accordance with quality system proceduresSupport internal audit activities and follow-up actionsParticipate in CAPA (Corrective and Preventive Action) and continuous improvement initiativesTrainingCollaborate with internal teams and external Subject Matter Experts to ensure regulatory course content remains current, accurate, and compliantSupport development and lead delivery of instructor-led workshopsProvide learner support on regulatory training courses where applicableGeneralMaintain professional development to stay current with relevant standards, regulations, and best practicesSupport company initiatives, webinars, blogs, and other thought leadership activities related to QA/RAPerform other duties as assigned by the CEO and/or QA/RA DirectorEssential Skills and ExperienceMinimum 4 years' experience working within regulated industries (MedTech, QA/RA roles etc.)Strong understanding of international regulatory frameworks (MDR, MDSAP, FDA QSR/QMSR, ISO 13485, ISO 9001)Experience working within a QMS (preferably ISO 9001 or ISO 13485)Excellent attention to detail and ability to manage multiple projects simultaneouslyStrong written and verbal communication skills, with the ability to interpret and communicate complex regulatory information clearlyCompetent in MS Office and document control systemsSelf-motivated and proactive, with a focus on compliance and quality improvementCollaborative and team-oriented, with a willingness to learn and take initiativeStrong organizational and problem-solving skillsCommitted to maintaining high standards of professional ethics and integrityAdaptable in a fast-paced, growing business environmentPreferred QualificationsBachelor's degree in Science, Engineering, Quality, or a related discipline (beneficial)Recognized training in Quality and Regulatory Affairs e.g. CQI-IRCA Certified MD-QMS Lead Auditor, MDSAP, MDR, or equivalent (beneficial)Train the Trainer certification (beneficial)BenefitsBonus, Healthcare & Pension