Director, Regulatory Affairs Medical Devices & Combination Product

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES: Acts as the Person Responsible for Regulatory Compliance (PRRC) RA for Takeda’s medical devices with in 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 ACCOUNTABILITIES: 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 V erifies 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 n ecessary adjustments to maintain regulatory compliance across Business Units for medical devices and comb ination 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. P rovides 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 <