Director, Regulatory Affairs Medical Devices & Combination Product

Director, Regulatory Affairs Medical Devices & Combination Product

Takeda

Dublin, Ireland

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)