{"id":990005,"url":"https://alion.io/job/takeda-director-regulatory-affairs-medical-devices-combination-product","title":"Director, Regulatory Affairs Medical Devices & Combination Product","company":{"id":5984,"name":"Takeda Pharmaceutical","domain":"takeda.com","url":"https://alion.io/company/takeda","size_band":"5000+","is_staffing_agency":false,"is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":80,"open_postings":22,"ghost_share":0,"stale_share":0.818,"repost_share":0,"time_to_fill_p50_days":22,"computed_at":"2026-09-24T05:45:00Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Dublin, Ireland"],"countries":["IE"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":116800,"max":160600,"currency":"EUR","period":"year","gross":null,"usd_annual":184449},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-15T00:00:00Z","employer_posted_date":"2026-09-15","last_verified_at":"2026-09-24T23:36:45Z","board_verified":true,"closed_at":null,"days_open":10,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":10},"description":"By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.\nJob Description\nOBJECTIVES:\nActs as thePerson Responsible for Regulatory Compliance (PRRC) RA forTakeda’s medical deviceswithinTakeda´sEUAuthorised Representative organization perEU Medical Device Regulation (MDR)2017/745.\n\nThe RA PRRC of the EU Authorised Representativeis responsible forensuring that the tasks of the AR are fulfilled in the context of regulatory requirements\n\nManages the liaisons to key regulatory authorities (e.g. notified bodies, competent authorities and others asrequired)in the European Economic Area (EEA), and others as needed\n\nACCOUNTABILITIES:\nThe PRRC RA role supports theEU Authorised representative duties, such asreviewing andverifyingthat the technical documentation and Declaration of Conformity are up-to-dateand ensures that the documentation is aligned withappropriateregulatoryrequirements and standards\n\nVerifies that device registration has been appropriately conducted\n\nOtherARresponsibilitiesper EU MDR 2017/745Art. 11may be in scope for this role\n\nPrepares the application andsubmitsthe documentation tothe Notified Bodyfor both medical devices and combination products\n\nApprovescosts, handles budget and POs for product specific projects for Notified Body\n\nEnsuresthat Takedacomplies withall applicable regulatory requirements for medical devices within the EuropeanEconomic Area (EEA), while ensuringhigh standardsof quality and safety.\n\nProactivelymonitorregulatory changesin the EEAandupdates,andsupports necessary adjustments tomaintainregulatorycomplianceacross Business Unitsfor medical devicesand combinationproducts.\n\nUtilizes technical device knowledge, regulatoryexpertiseand global regulatory lessons learned to shapeEEAregulatory best practices, drive internalconsistencyand influence effective change management\n\nAccountable to deliver onEEAstrategies across Business Units and driving consistency and efficient processes to deliver on launches, regulatory change and authority and legal requests.\n\nProvides technical,strategicand tactical regulatory guidance to product teams by defining andoptimizingEEAregulatory strategiespertaining tothe development, registration,commercializationand life cycle management of assigned products\n\nProactivelyidentifies,analysesand manages combination product and device-related regulatory risks, ensuringtimelycommunication with relevant stakeholders and management\n\nInforms strategy for device-relatedand combination productaspects ofEEAregulatory submissions (e.g.,CE-marking, Notified Body Opinions,Variations, etc.)\n\nBuilds and manages strong working relationships through active partnering with key internal and external stakeholders\n\nProvidesEEAregulatory input and guidance on product-compliance related activities including change controls, deviations, and investigations\n\nResponsible for authoring regional specific documentation for medical devices and combination products (e.g. Essential Principles Checklist per Australian requirements).\n\nWorks effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy,Labeling, etc) to ensure effective strategies are developed and project execution is on target\n\nMay serve as mentor to other GRA Device Regulatory staff members\n\nResponsible fordemonstratingTakeda leadershipbehaviours\n\nLead and attend applicable industry associations\n\nProvide necessary audit support from a device regulatory perspective\n\nOther global responsibility & markets may be in scope for this role pending on need\n\nEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:\nBS/BA Degreefrom an EU Member Statein a Scientific Discipline\n\n10+ yearsof RegulatoryMedicalDevice experiencefor EU and international markets. Experience as a Device regulatory lead for drug-device combination products(drug-delivery products)is preferred.\n\nExperienceworking oncross-functional submission teams\n\nSolid understanding of scientific principles and regulatory requirements relevant to global drug-device combination product development,registrationand post-market support\n\nDemonstratedtrack recordof successful interactionswithNotified Bodies and other global health authorities, includingdevice submissions.EMAinteractions and submissions,specifically related to Combination ProductsandDrug-Deliveryexperience(i.e., Notified Body Opinions, etc.) is preferred\n\nAble toidentify, prioritize and resolve issues of critical importance;providesound regulatory advice and make informed decisions on regulatory issues for which there may not be clear/specific regulatory guidance\n\nDemonstrate leadership, problem-solving ability,flexibilityand teamwork\n\nExercise good judgement in elevating and communicating actual or potential issues to line management\n\nExcellent written and oral communication skillsrequired\n\nAbility to partner and influence key stakeholders.\n\nExpert knowledge of regulatory requirements (e.g. MDR, drug-led combination products) and ability to translate regulations into clear data requirements\n\nAbility to persuasively communicate with notified bodies technical reviewers andEU Heath Authorities\n\nA strong results-orientation, organised and a keensense of urgency\n\nFluent in English (required) and in another European language (desired)\n\nTRAVEL REQUIREMENTS:\nWillingness to travel to various meetings or client sites, including overnight trips. Some international travel may berequired.\n\nRequiresapproximately10-30% travel\n\nLocations\nDublin-Baggot Street, IrelandBase Salary Range:\n€116,800.00 - €160,600.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.\nFor information about our benefits, please click here.\nWorker Type\nEmployeeWorker Sub-Type\nRegularTime Type\nFull time","description_format":"text","description_chars":6440,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Medical Devices","Health & Medical Electronics","Biotechnology","Biopharma"],"lifecycle":[{"event":"open","at":"2026-09-17T01:59:30Z"}],"liveness":{"score":55,"band":"ok","label":"Likely open","p_open":1,"p_active":0.612,"p_room":0.9,"age_days":9,"expected_fill_days":22,"reasons":["conf:0","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-09-24T05:45:00Z"},"pay":{"stated_usd_annual":184449,"is_top_pay":false},"html_url":"https://alion.io/job/takeda-director-regulatory-affairs-medical-devices-combination-product","json_url":"https://alion.io/job/takeda-director-regulatory-affairs-medical-devices-combination-product.json","meta":{"generated_at":"2026-09-25T01:07:27Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":1062,"day_limit":5000,"remaining_today":3938,"minute_limit":60,"resets_at":"2026-09-26T00:00:00Z"}}}