Director, Medical Devices EU

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Job Description
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OBJECTIVES:

• Acts as the Person Responsible for Regulatory Compliance (PRRC) RA for Takeda’s medical devices within Takeda´s EU Authorised Representative organization per EU Medical Device Regulation (MDR) 2017/745\.


• The RA PRRC of the EU Authorised Representative is responsible for ensuring 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 required) in the European Economic Area (EEA), and others as needed

• The PRRC RA role supports the EU Authorised representative duties, such as reviewing and verifying that the technical documentation and Declaration of Conformity are up\-to\-date and ensures that the documentation is aligned with appropriate regulatory requirements and standards


• Verifies that device registration has been appropriately conducted


• Other AR responsibilities per EU MDR 2017/745 Art. 11 may be in scope for this role


• Prepares the application and submits the documentation to the Notified Body for both medical devices and combination products


• Approves costs, handles budget and POs for product specific projects for Notified Body


• Ensures that Takeda complies with all applicable regulatory requirements for medical devices within the European Economic Area (EEA), while ensuring high standards of quality and safety.


• Proactively monitor regulatory changes in the EEA and updates, and supports necessary adjustments to maintain regulatory compliance across Business Units for medical devices and combination products.


• Utilizes technical device knowledge, regulatory expertise and global regulatory lessons learned to shape EEA regulatory best practices, drive internal consistency and influence effective change management


• Accountable to deliver on EEA strategies across Business Units and driving consistency and efficient processes to deliver on launches, regulatory change and authority and legal requests.


• Provides technical, strategic and tactical regulatory guidance to product teams by defining and optimizing EEA regulatory strategies pertaining to the development, registration, commercialization and life cycle management of assigned products


• Proactively identifies, analyses and manages combination product and device\-related regulatory risks, ensuring timely communication with relevant stakeholders and management


• Informs strategy for device\-related and combination product aspects of EEA regulatory 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


• Provides EEA regulatory 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 for demonstrating Takeda leadership behaviours


• 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 Degree from an EU Member State in a Scientific Discipline


• 10\+ years of Regulatory Medical Device experience for EU and international markets. Experience as a Device regulatory lead for drug\-device combination products (drug\-delivery products) is preferred.


• Experience working on cross\-functional submission teams


• Solid understanding of scientific principles and regulatory requirements relevant to global drug\-device combination product development, registration and post\-market support


• Demonstrated track record of successful interactions with Notified Bodies and other global health authorities, including device submissions. EMA interactions and submissions, specifically related to Combination Products and Drug\-Delivery experience (i.e., Notified Body Opinions, etc.) is preferred


• Able to identify, prioritize and resolve issues of critical importance; provide sound regulatory advice and make informed decisions on regulatory issues for which there may not be clear/specific regulatory guidance


• Demonstrate leadership, problem\-solving ability, flexibility and teamwork


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


• Excellent written and oral communication skills required


• 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 and EU Heath Authorities


• A strong results\-orientation, organised and a keen sense 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 required.


• Requires approximately 10\-30% travel

Dublin\-Baggot Street, IrelandBase Salary Range:

€116,800\.00 \- €160,600\.00

For information about our benefits, please click here.

Worker Type
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EmployeeWorker Sub\-Type
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RegularTime Type
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Full time

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