Our client, a leading diagnostic specialist, based in Limerick, have a requirement for a Regulatory Manager who will drive and manage the regulatory team ensuring the company is compliant in all regulatory and legal requirements.So, if you are an experienced Regulatory Manager who wants to make a significant impact and contribute to the success of a dynamic organisation, please apply todayThe Role:Reporting to the Chief Operations Officer, the Regulatory Manager responsibilities will include the following:Guide, coach, direct and develop direct reportsDetermine team priorities and resolve any conflicts for department resourcesConduct project/team meetings regularly to ensure work programs are tracking to plan, providing information and input, assigning work, and resolving any issuesOversee the regulatory strategy implementation and control within the regulatory teamManage and maintain technical documentation for existing Class A and B IVD products, including technical review of documentsManage the internal post-market surveillance and risk management processesCoordination of vigilance reporting for CE-IVD, & any other approved territory reporting ensuring all regulatory reporting timelines are metManage and maintain existing regulatory clearance/certification and filings in new territoriesManage regulatory submission timelines, identify risks, and appropriate mitigationsAdvise on regulatory strategies for existing, changing, and non-conforming products in collaboration with R&D, Manufacturing and Technical departments, as appropriateMaintain knowledge of current regulatory environment in relevant markets to ensure that information is adequately communicated throughout the company relating to changes in the regulatory environmentAct as deputy Person Responsible for Regulatory Compliance, as requiredSkills & Experience that we need:BSc in Molecular Biology or a relevant disciplineMinimum 5 years' experience working in a regulatory role for a Medical Device or In Vitro Diagnostic CompanyAt least 2 years' experience managing, or supervising team membersExcellent working knowledge of ISO 13485 and IVDR/MDRAbility to manage competing priorities in a fast-paced environmentStrict attention to detail in all aspects of the roleAbility to interact professionally with all organisation levelsExcellent communication and interpersonal skillsKnowledge and understanding of software as a medical device and associated guidance and standards- DesirableExperience engaging with Notified Bodies or international Regulatory Authorities during conformity assessment process – DesirableThe Offer:This is a permanent, onsite role, based in Limerick, with salary to reflect the candidates experience, with excellent benefits package.This is a fully onsite role based in Limerick so candidates should be based locally or a commutable distance.How to Apply:If you are interested in applying, or want to know more about this role please contact,Orlaigh FitzGerald-Quinn in Cpl Limerick on or email your CV to (email protected).For a full list of our open jobs, please have a look