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) ********.
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 and for managing liaisons to key regulatory authorities (e.g., notified bodies, competent authorities, and others as required) in the European Economic Area (EEA).
ACCOUNTABILITIES
Supports EU Authorised Representative duties by reviewing and verifying that the technical documentation and Declaration of Conformity are up-to-date and aligned with regulatory requirements and standards.
Verifies that device registration has been appropriately conducted and that other AR responsibilities per EU MDR Art.11 may be in scope.
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 the Notified Body.
Ensures Takeda complies with all applicable regulatory requirements for medical devices within the EEA, maintaining high standards of quality and safety.
Proactively monitors regulatory changes in the EEA and supports necessary adjustments to maintain compliance across Business Units.
Utilizes technical device knowledge, regulatory expertise, and global lessons learned to shape EEA regulatory best practices, drive internal consistency, and influence effective change management.
Provides technical, strategic, and tactical regulatory guidance to product teams by defining and optimizing EEA regulatory strategies for development, registration, commercialization, and life-cycle management of assigned products.
Identifies and manages combination product and device-related regulatory risks, ensuring timely communication with 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 activities including change controls, deviations, and investigations.
Authors 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 to ensure effective strategies are developed and project execution is on target.
Might serve as mentor to other GRA Device Regulatory staff members.
QUALIFICATIONS
Education:
BS/BA Degree from an EU Member State in a Scientific Discipline.
Experience:
10+ years of Regulatory Medical Device experience for EU and international markets; preferred experience as a Device regulatory lead for drug-device combination products; 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 and EMA interactions.
Skills and Competencies:
Able to identify, prioritize and resolve critical issues; provide sound regulatory advice and make informed decisions under unclear guidance; demonstrate leadership, problem-solving ability, flexibility, teamwork; exercise good judgement in elevating and communicating actual or potential issues to line management; excellent written and oral communication; 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; persuasively communicate with notified bodies technical reviewers and EU Health Authorities; strong results-orientation, organized and keen sense 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 be required; approximately *****% travel.
LOCATION
Dublin-Baggot Street, Ireland.
BASE SALARY RANGE
€116,****** – €160,******.
EMPLOYEE DETAILS
Worker Type: Employee; Worker Sub-Type: Regular Time; Full time.
LEGAL & EEO STATEMENTS
Takeda is an equal opportunity employer.
For applicants of U.S. and Puerto Rico positions: Information about our commitment to Equal Employment Opportunity (EEO).
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