Find Unit director Jobs in Dublin, D

Director, Regulatory Affairs Medical Devices & Combination Product
Takeda Pharmaceutical —Dublin, County Dublin
- €116,800–€160,600 a year
- Full-time
- English
- Bachelor's degree
- Communication skills
Business Unit Commissioning Manager
Mercury Engineering —Dublin, County Dublin
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
Patient Flow Coordinator (CNM1)
Bartra Healthcare —Kilmore, County Dublin
- From €60,000 a year
- Full-time
- Nursing
- Management
- Project management
Quick apply
3d
Senior Procurement Director, Sugar EMEA
Coca-Cola —Dublin, County Dublin
- Full-time
- Master's degree
- Analysis skills
- Bachelor's degree
2d
Associate Director - Privacy Technologies
Grant Thornton —Dublin, County Dublin
- Full-time
- Azure
- Master's degree
- AI
FS Project Manager – Associate Director - Dublin / Belfast
Grant Thornton —Dublin, County Dublin
- Full-time
- Management
- Business development
- Analysis skills
13d
Technical Director - Dublin or Cork
ENGIE —DUBLIN 2, County Dublin
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Engineering
- Annual leave
Head of Procurement
Sisk —Dublin, County Dublin
- Full-time
- No degree
- Construction experience
- Business
- Annual leave
Trial Vendor Associate Director
Novartis —Dublin, County Dublin
- €75,880–€140,920 a year
- Full-time
- No degree
- Communication skills
Director of Project Management
IPS-Integrated Project Services —DUBLIN 12, County Dublin
- Full-time
- Engineering
- Project management
- Bachelor's degree
10d
Senior Physiotherapist
Bartra Healthcare —DUBLIN 5, County Dublin
- €63,279–€67,399 a year
- Full-time
- Management
- Supervising experience
- Bachelor's degree
Quick apply
Director - Sales
Wesco —Dublin, County Dublin
- Full-time
- Sales
- Engineering
- Bachelor's degree
- Employee assistance program
3d
Assistant Director of Nursing
Grace Healthcare of Dublin —Dublin, County Dublin
- Management
- Research
- First Aid Certification
- Employee assistance program
Director Network Supply Planning
AstraZeneca —Dublin, County Dublin
- Engineering
- Master's degree
- Bachelor's degree
Associate Director - Environmental Health and Safety
Vantive —Dublin, County Dublin
- Remote
- Engineering
- English
- Master's degree
Crop Protection Manager
Keelings —Saint Margaret's, County Dublin
- Full-time
- Microsoft Excel
- English
- Leadership
Quick apply
Program Director E2E Planning Transformations
Bluecrux —Dublin, County Dublin
- Full-time
- Hybrid work
- English
- Master's degree
- No degree
Quick apply
Project Director
Cunningham Contracts —DUBLIN 22, County Dublin
- Full-time
- No degree
- Construction experience
- Communication skills
- Annual leave
- Employee assistance program
Quick apply
10d
Renewables Portfolio Lead Ireland
AECOM —Dublin, County Dublin
- Full-time
- Hybrid work
- Engineering
- Business development
- Bachelor's degree
Global Labelling Director, Content
Novartis —Dublin, County Dublin
- €90,300–€167,700 a year
- Full-time
- Hybrid work
- Leadership
21h

I want to receive the latest job alerts for unit director in dublin, d

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

unit director jobs near dublin, d

Sales Director jobs in Dublin, County Dublin

Shift Leader jobs in Dublin, County Dublin

Project Director jobs in Dublin, County Dublin

Supply Chain Specialist jobs in Dublin, County Dublin

Medical Director jobs in Dublin, County Dublin

Associate Director jobs in Dublin, County Dublin

Director Of Technology jobs in Dublin, County Dublin

Commissioning Manager jobs in Dublin, County Dublin

Sales Director jobs in Cork, County Cork

Sales Director jobs in Galway, County Galway

Sales Assistant Charlestown, Finglas, Dublin 11 jobs in Dublin, County Dublin

Sales Consultant, Currys Pc World jobs in Galway, County Galway

Sales Director jobs in Coolock, County Dublin

Sales Director jobs in Naas, County Kildare

Sales Assistant, Flying Tiger jobs in Dublin, County Dublin

Sales jobs in Kilkenny, County Kilkenny

Night Shift jobs in Tralee, County Kerry

Night Shift 12 Hour Shift jobs in Dublin, County Dublin

Night Shift jobs in Swords, County Dublin

Shift Leader jobs in Dún Laoghaire, County Dublin

Director, Regulatory Affairs Medical Devices & Combination Product

Takeda Pharmaceutical -
Dublin, County Dublin

Apply Now

Job details

Full-time
€116,800–€160,600 a year

Qualifications

English
Bachelor's degree
Communication skills

Full job description

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

Apply Now

Refine Your Search

unit director jobs in dublin, d

Director, Regulatory Affairs Medical Devices & Combination Product

Business Unit Commissioning Manager

Patient Flow Coordinator (CNM1)

Senior Procurement Director, Sugar EMEA

Associate Director - Privacy Technologies

FS Project Manager – Associate Director - Dublin / Belfast

Technical Director - Dublin or Cork

Head of Procurement

Trial Vendor Associate Director

Director of Project Management

Senior Physiotherapist

Director - Sales

Assistant Director of Nursing

Director Network Supply Planning

Associate Director - Environmental Health and Safety

Crop Protection Manager

Program Director E2E Planning Transformations

Project Director

Renewables Portfolio Lead Ireland

Global Labelling Director, Content

I want to receive the latest job alerts for unit director in dublin, d

Related Searches

Explore jobs in more locations

Job Description

Locations

Worker Type

Worker Sub-Type

Time Type

Jobseeker tools

Employer Tools

Browse

Stay Connected