Job Title: Product Regulatory Manager Location: Shannon, Co.
Clare, Ireland Reporting To: Group Commercial Manager Ei Electronicsisa 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.
Job Purpose: 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.
Key Responsibilities: *Regulatory Strategy&Oversight: Develop, implement, and maintain a comprehensive global regulatory compliance strategy forall Ei 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, Ro HS, WEEE, UKCA, UL, CE, BSI, Vd S,etc.).
Provideexpertguidanceandsupportto R&D, Quality, Manufacturing, Sales,and Marketingteamson regulatoryrequirementsthroughout theproduct lifecycle,fromconcept to end-of-life.
Proactivelyidentifypotentialregulatoryrisksandopportunities,developingmitigation strategies and action plans.
*Product Approvals&Certification: Manageandoverseeallaspectsofproduct approvalsandcertificationsfor new and existing products across various global markets.
Prepare and submit comprehensive technical documentation, test reports, and declarationsofconformityto Notified Bodies,certificationagencies,andregulatory authorities.
Coordinateandfacilitateallnecessaryproducttestingwithinternalandexternal laboratories to ensure compliance with relevant standards.
Maintainand update allproduct certifications, licenses, and declarations, ensuring their ongoingvalidity.
*Notified Body&Regulatory Authority Interactions: Actastheprimarypointofcontactandleadallinteractionswith Notified Bodies, national regulatory authorities, and other certification bodies.
Manageandfacilitateaudits,inspections,andassessmentsby Notified Bodiesand regulatory agencies.
Respondtoinquiries,addressdeficiencies,andnegotiatewithregulatorybodiesto achievetimelyproductapprovalsandresolvecomplianceissues.
*Buildandmaintainstrongworkingrelationshipswithkeyregulatorystakeholders.
*Documentation&Quality Management Systems: Establish and maintain robust regulatory documentation systems, ensuring accurate, complete, and readily accessible records of all approvals, certifications, and compliance activities.
Collaboratewiththe Qualityteamtointegrateregulatoryrequirementsintothe company's Quality 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& Compliance Maintenance: 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'sdegreein Engineering, Science, Law, ora related technicaldiscipline.
Minimumof3yearsofexperienceinadedicated Product 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 Products Regulation(CPR), Radio Equipment Directive (RED), Low Voltage Directive (LVD), EMC Directive, Ro HS, WEEE, REACH, UKCA marking, UL, BSI, Vd S 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