Director, Regulatory Affairs Medical Devices & Combination Product

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Job Description

OBJECTIVES:

• Acts as thePerson Responsible for Regulatory Compliance (PRRC) RA forTakeda’s medical deviceswithinTakeda´sEUAuthorised 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 asrequired)in the European Economic Area (EEA), and others as needed

ACCOUNTABILITIES:

• 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 EEAandupdates,andsupports 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 technical,strategicand tactical regulatory guidance to product teams by defining andoptimizingEEAregulatory strategiespertaining tothe development, registration,commercializationand life cycle management of assigned products

• Proactivelyidentifies,analysesand 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 Opinions,Variations, 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, Strategy,Labeling, 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

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• 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 development,registrationand post-market support

• Demonstratedtrack 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

• 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 ability,flexibilityand teamwork

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

• Excellent written and oral communication skillsrequired

• 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)

TRAVEL REQUIREMENTS:

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may berequired.

• Requiresapproximately10-30% travel

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Base Salary Range:

The 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.

For information about our benefits, please click here.

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