HADER SOLUTIONS & DISTRIBUTION LTD based in Dublin, acts as the Legal Manufacturer of our Swiss-Made dental medical devices and leads all regulatory, conformity, and worldwide market distribution activities. Regulatory Expert (m/f/d) As part of our growth, we are strengthening our regulatory capabilities and are looking for a dedicated and experienced Regulatory Expert to join our team to assure regulatory compliance for our dental product. Mission and Responsibilities Create, Maintain and optimize the Technical Documentation (TD) of our products ManagementofRegistrationofnewproducts ManageCorrespondencewithAuthoritiesandNotifiedBody Drivecross-departmentalcollaborationtogatherinputsforTDupdates EnsurefullcomplianceofourTDwithcurrentregulations(EUMDRandapplicablestandards) Monitorregulatorychangesandmaintaincomplianceaccordingly Qualifications: At least 3 years of experience in Regulatory Affairs for Medical Devices In-depthknowledgeofEUMDRandrelevantapplicablestandards Monitorregulatorychangesandmaintaincomplianceaccordingly SolidknowledgeofTechnicalDocumentationanditspracticalapplication Autonomous,pragmatic,andsolution-orientedmindset ExperiencewithglobalregulatorysubmissionsorproductregistrationsoutsidetheEU(e.g.FDA, UK MDR, Health Canada, Asian or LATAM authorities) is a plus KnowledgeofQMSPrograms(e.g.M-Files)isanasset FluentinEnglish(otherlanguagesareanadvantage) We offer: Growth in a competitive environment related perspective of self-development. Attractiveandmodernconditionswithadaptedincentives/benefits(Pensionplan+insurance, flexible hours, company offered holidays, etc.) A hybrid working model with flexibility for remote work Please click apply below with CV and references.
