We're looking for a Senior Regulatory Affairs Specialist for a fast growing med tech company based Cork (Ireland). The successful candidate will collaborate with cross-functional teams to facilitate regulatory approvals, manage submissions, and maintain compliance with evolving regulatory requirements. This position offers an excellent compensation package and potentially hybrid working.ResponsibilitiesRegulatory Strategy Development: Formulate and execute strategies for product registration, approval, and complianceDaily Regulatory Management: Oversee day-to-day regulatory activities and manage multiple projects related to regulatory complianceSubmission Management: Prepare, maintain, review, and submit regulatory documents and applications to health authoritiesGlobal Registration Support: Assist the team in obtaining and retaining country-specific regulatory registrations worldwideMDSAP Implementation: Manage the implementation of the Medical Device Single Audit Program within the organizationRegulatory Compliance Monitoring: Ensure compliance with national and international regulatory requirements and quality standardsRisk Assessment: Identify and assess potential regulatory risks and propose effective mitigation strategiesCross-Functional Collaboration: Work closely with QA, R&D, Operations, Clinical Affairs, and other departments to integrate regulatory requirements into QMS and product development processesRegulatory Updates: Stay current with changing regulations, guidelines, and industry trendsMaintain high-quality standards within the organization by assessing risk profiles and creating mitigation programs/tools.Post Market Surveillance: Manage activities including logging customer complaints and adverse events, coordinating investigations, and conducting regulatory trending and reportingCE Mark Submissions: Handle submissions, significant change notifications, and interactions with Notified BodiesInternational Filings: Support the team with the preparation of international regulatory filings, including 510(k) submissions and FDA correspondenceMaterial Review: Ensure public-facing materials comply with regulatory standardsSkills and QualificationsBachelor's degree in Engineering or Science or practical expertiseRegulatory experience in the medical device industryUnderstanding of ISO 13485, ISO 14971, EU MDR, UK, MDSAP, 21 CFR 820, and supporting standardsPlease click to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.To find out more about Real, please visit Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC(phone number removed) England and Wales