Director, Regulatory Affairs Medical Devices & Combination Product

Acts as thePerson Responsible for Regulatory Compliance (PRRC) RA forTakedas medical deviceswithinTakedasEUAuthorised Representative organization perEU Medical Device Regulation (MDR)2017/745.

The RA PRRC of the EU Authorised Representativeis responsible forensuring that the tasks of the AR are fulfilled in the context of regulatory requirements

Manages the liaisons to key regulatory authorities (e.g. notified bodies competent authorities and others as)in the European Economic Area (EEA) and others as needed

The 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

Verifies that device registration has been appropriately conducted

OtherARresponsibilitiesper EU MDR 2017/745Art. 11may be in scope for this role

Prepares the application andsubmitsthe documentation tothe Notified Bodyfor both medical devices and combination products

Approvescosts handles budget and POs for product specific projects for Notified Body

Ensuresthat Takedacomplies withall applicable regulatory requirements for medical devices within the EuropeanEconomic Area (EEA) while ensuringhigh standardsof quality and safety.

Proactivelymonitorregulatory changesin the EEAandupdatesandsupports necessary adjustments tomaintainregulatorycomplianceacross Business Unitsfor medical devicesand combinationproducts.

Utilizes technical device knowledge regulatoryexpertiseand global regulatory lessons learned to shapeEEAregulatory best practices drive internalconsistencyand influence effective change management

Accountable to deliver onEEAstrategies across Business Units and driving consistency and efficient processes to deliver on launches regulatory change and authority and legal requests.

Provides technicalstrategicand tactical regulatory guidance to product teams by defining andoptimizingEEAregulatory strategiespertaining tothe development registrationcommercializationand life cycle management of assigned products

Proactivelyidentifiesanalysesand manages combination product and device-related regulatory risks ensuringtimelycommunication with relevant stakeholders and management

Informs strategy for device-relatedand combination productaspects ofEEAregulatory submissions (e.g.CE-marking Notified Body OpinionsVariations etc.)

Builds and manages strong working relationships through active partnering with key internal and external stakeholders

ProvidesEEAregulatory input and guidance on product-compliance related activities including change controls deviations and investigations

Responsible for authoring regional specific documentation for medical devices and combination products (e.g. Essential Principles Checklist per Australian requirements).

Works effectively across a complex matrix environment in GRA with GRLs CMC RA project leads and other GRA sub-functions (e.g. Growth & Emerging Markets StrategyLabeling etc) to ensure effective strategies are developed and project execution is on target

May serve as mentor to other GRA Device Regulatory staff members

Responsible fordemonstratingTakeda leadershipbehaviours

Lead and attend applicable industry associations

Provide necessary audit support from a device regulatory perspective

Other global responsibility & markets may be in scope for this role pending on need

BS/BA Degreefrom an EU Member Statein a Scientific Discipline

10 yearsof RegulatoryMedicalDevice experiencefor EU and international markets. Experience as a Device regulatory lead for drug-device combination products(drug-delivery products)is preferred.

Experienceworking oncross-functional submission teams

Solid understanding of scientific principles and regulatory requirements relevant to global drug-device combination product developmentregistrationand post-market support

Demonstratedtrack recordof successful interactionswithNotified Bodies and other global health authorities includingdevice submissions.EMAinteractions and submissionsspecifically related to Combination ProductsandDrug-Deliveryexperience(i.e. Notified Body Opinions etc.) is preferred

Able 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

Demonstrate leadership problem-solving abilityflexibilityand teamwork

Exercise good judgement in elevating and communicating actual or potential issues to line management

Excellent written and oral communication skills

Ability to partner and influence key stakeholders.

Expert knowledge of regulatory requirements (e.g. MDR drug-led combination products) and ability to translate regulations into clear data requirements

Ability to persuasively communicate with notified bodies technical reviewers andEU Heath Authorities

A strong results-orientation organised and a keensense of urgency

Fluent in English (required) and in another European language (desired)

Willingness to travel to various meetings or client sites including overnight trips. Some international travel may be.

Requiresapproximately10-30% travel