Product Regulatory Manager

Job Title: Product Regulatory Manager Location: Shannon, Co.
Clare, Ireland ReportingTo:GroupCommercialManager EiElectronicsisa worldleaderinthedesignandmanufactureofresidentialfireandcarbon monoxide detection products.
With a strong commitment to quality and innovation, we ensure our products meet the highest safety and performance standards globally.
We are seeking a highly experienced and proactive Product Regulatory Manager to lead our effortsinnavigatingthecomplexlandscapeofinternationalregulationsand standards.
JobPurpose: The Product Regulatory Manager will be responsible for defining, implementing, and maintaining Ei Electronics' global regulatory compliance strategy across all product lines.Thispivotalrolewillensurethatallproductsmeetrelevantnationaland international safety, performance, and environmental standards, facilitate successful productapprovals, and manage all interactions with Notified Bodies and other regulatory authorities.
KeyResponsibilities: *RegulatoryStrategy&Oversight: Develop, implement, and maintain a comprehensive global regulatory compliance strategy forallEi Electronics products, ensuring alignment with business objectives and market expansion plans.
Monitorand interpret new and evolvingnational, regional, and internationalregulations,standards, and directives relevant to fire and carbon monoxide detection products (e.g., CPR,RED,LVD, EMC,RoHS,WEEE, UKCA,UL,CE,BSI,VdS,etc.).
ProvideexpertguidanceandsupporttoR&D,Quality,Manufacturing,Sales,and Marketingteamson regulatoryrequirementsthroughout theproduct lifecycle,fromconcept to end-of-life.
Proactivelyidentifypotentialregulatoryrisksandopportunities,developingmitigation strategies and action plans.
*ProductApprovals&Certification: Manageandoverseeallaspectsofproduct approvalsandcertificationsfor new and existing products across various global markets.
Prepare and submit comprehensive technical documentation, test reports, and declarationsofconformitytoNotifiedBodies,certificationagencies,andregulatory authorities.
Coordinateandfacilitateallnecessaryproducttestingwithinternalandexternal laboratories to ensure compliance with relevant standards.
Maintainand update allproduct certifications, licenses, and declarations, ensuring their ongoingvalidity.
*NotifiedBody&RegulatoryAuthorityInteractions: ActastheprimarypointofcontactandleadallinteractionswithNotifiedBodies, national regulatory authorities, and other certification bodies.
Manageandfacilitateaudits,inspections,andassessmentsbyNotifiedBodiesand regulatory agencies.
Respondtoinquiries,addressdeficiencies,andnegotiatewithregulatorybodiesto achievetimelyproductapprovalsandresolvecomplianceissues.
*Buildandmaintainstrongworkingrelationshipswithkeyregulatorystakeholders.
*Documentation&QualityManagementSystems: Establish and maintain robust regulatory documentation systems, ensuring accurate, complete, and readily accessible records of all approvals, certifications, and compliance activities.
CollaboratewiththeQualityteamtointegrateregulatoryrequirementsintothe company'sQuality Management System (QMS)(e.g., ISO9001, EN13980for CPR).
Developanddelivertrainingprogramstointernalteamsonregulatorycompliance requirements and best practices.
Ensure allproduct labelling, user manuals,and marketing materials comply with relevant regulatory requirements.
*Post-Market Surveillance& ComplianceMaintenance: Support post-market surveillanceactivities, includingthereview ofproduct complaints and incidents for potential regulatory impact.
Manageandtrackchangestoexistingproductstoensurecontinued compliancewith evolvingregulations.
Initiateandmanagerecallactivitiesifrequired,incollaborationwithrelevantinternal departments and regulatory bodies.
Skills&Experience: *Essential: *Bachelor'sdegreeinEngineering,Science,Law, ora related technicaldiscipline.
Minimumof3yearsofexperienceinadedicatedProduct Regulatoryrolewithin a manufacturing environment, ideally in electronics, consumer goods, or a similarly regulated industry.
Proven in-depth knowledge and practical experience with key international regulatory frameworks and standards relevant to regulated products (e.g., Construction ProductsRegulation(CPR), RadioEquipment Directive (RED), Low Voltage Directive (LVD), EMC Directive, RoHS, WEEE, REACH, UKCA marking, UL, BSI, VdS standards).
Demonstrable experience inmanaging complex product approvalprocessesfrom start to finish, including interactions with Notified Bodies.
Strongunderstandingofqualitymanagementsystems(e.g.,ISO9001)andtheir application in a regulatory context.
Excellentwrittenandverbalcommunicationskills,withtheabilitytoarticulatecomplex regulatory information clearly and concisely to diverse audiences.
Highlyorganised,meticulous,anddetail-oriented,withstrongprojectmanagement skills.
Proactive,self-motivated,andabletoworkindependentlyaswellascollaboratively within a team.
*Desirable: *Master'sdegreeorhigherinarelevantfield.
*Experienceinthefiresafetyorsecurityindustry.
*Experiencewithglobalmarketaccessstrategies.
*Legalbackgroundorspecificqualificationinregulatoryaffairs.
Fluencyinadditionallanguagesrelevanttokeyexportmarkets.
Personal Attributes *Highlevelofintegrityandethicalconduct.
*Stronganalyticalandproblem-solvingabilities.
*Abilitytoinfluenceandpersuadestakeholdersatalllevels.
*Resilienceandadaptabilityinafast-paced,evolvingregulatorylandscape.
Commitment tocontinuouslearningand professionaldevelopment.
What Ei Electronics Offers: Competitivesalaryandbenefitspackage.
*Opportunitytoworkwitha market-leadingcompanywitha strongglobalpresence.
*Achallengingandrewardingroleattheforefrontofproductsafetyandcompliance.
*Supportforprofessionaldevelopmentandcontinuouslearning.
A collaborative and supportive work environment.
Skills: Product Regulatory Experience Electronic Consumer Products International Regulatory Frameworks