Director, Regulatory Affairs Medical Devices & Combination Product

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 Takeda complies with all applicable regulatory requirements for medical devices within the EEA, while maintaining 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.
• Delivers on EEA strategies across Business Units and drives consistency and efficient processes to deliver 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 development, registration, commercialization and life cycle management of assigned products.
• Proactively identifies, analyzes 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 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 behaviors.
• 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 EMA interactions and submissions, specifically related to Combination Products and Drug-Delivery experience 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 Health 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