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 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

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

• 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

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• 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)

TRAVEL REQUIREMENTS:

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

• Requires approximately 10-30% travel

Locations
Dublin-Baggot Street, Ireland

Base Salary Range:
€116,800.00 - €160,600.00

For information about our benefits, please click here.

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time