Director, Regulatory Affairs Medical Devices & Combination Product

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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

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

For information about our benefits, please click here.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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