Regulatory Affairs Manager

Benefits:·         Company contributed pension·         Private Health Insurance·         Educational assistance programme·         Development & progression opportunities Vitalograph is the world’s leading manufacturer of medical respiratory diagnostic devices and software, used in the diagnosis of respiratory disorders, and advanced high-reliability equipment and software systems used in respiratory end-point clinical drug trials. We design and manufacture respiratory diagnostic devices, software, and consumables for healthcare professionals, for almost 60 years, and serve customers in over 100 countries. Headquartered in the UK, Vitalograph has operations in Ireland, Germany and the USA.  We now have an excellent opportunity available for a ‘Regulatory Affairs Manager’ in our facility in Ennis. With over 60 years in business and stability in the market, now is a very exciting time to join our expanding organisation. Responsibilities as a Regulatory Affairs Manager:·      Manage RA personnel·      Foster and champion a regulatory culture within the business·      Ensure that relevant global Regulatory Compliance requirements are identified, defined, documented, implemented, complied with, and sustained, including product safety requirements for the markets served·      Ensure compliance with the following medical device & software quality requirements; o  EU Medical Device Directive and Medical Device Regulation guidelines and associated QSRs, such as the MEDDEVso  ISO13485 Medical Device QMSo  MDSAP program member Quality System Regulations & associated documentso  US FDA 21 CFR Part 11 guidanceo  ICH E6 GCPo  Other jurisdictional QSRs as related to Regulatory submissions·      Facility & device registering, licencing and device change management etc., within applicable jurisdictions, including supporting licence holders with documentation etc. Assure conformity of devices is appropriately checked, in accordance with the documented QMS under which the devices are manufactured, before a device is released·      Ensure technical documentation and the EU declaration of conformity are drawn up and kept up to date·      Ensure that post-market surveillance obligations, including Reporting obligations, are complied with in accordance with the various regulations and or directives·      Host Regulatory Inspections, Notified Body and customer onsite or remote audits·      Prepare and or support Regulatory filings;o  CE Marking submissions for MDD and MDRo  US FDA submissionso  Notified Body registrationso  ROW registrationso  Oversight of AE or related Reporting to Regulatory Authorities·      Maintain the product and establishment registrations·      Support Clinical Trial Teams and Sponsors regarding device conformity and registration queries·      Maintain regulatory oversight, plan and implement change programs to ensure continued compliance·      Identify and maintain key essential quality KPIs including regular reporting of quality metrics and issues·      Be the site regulatory representative on design teams including risk management approvals, NPI and design transfer·      Participate in and give training on regulatory matters·      Prepare and submit annual plans with focussed targets and associated budget Requirements as a Regulatory Affairs Manager::Minimum BSc/BEng degree in a science or technical discipline with a relevant postgraduate qualification a distinct advantageHave completed post-qualification quality and regulatory trainingMinimum ten years’ experience in medical device quality and/or regulatory areasIn-depth understanding of FDA Class II and EU MDD / MDR class IIa medical device requirements and regulationsExperience of implementing and maintaining ISO 13485 Experience of hosting regulatory body notified body and customer auditsInterpersonal skills and professional skills to interact at all levels including senior management, contractors and colleaguesPeople management and supervisory experience Experience of ICH E6 GCP requirements would be an advantageStrong problem-solving and analytical skills