Find Senior clinical data Jobs in Tallaght County Dublin

Senior Risk Management Engineer / Scientist
Viatris —Northern Cross, County Dublin
- Full-time
- Analysis skills
- Communication skills
Senior Software Development Engineer
Solventum —Dublin, County Dublin
- Full-time
- Hybrid work
- DevOps
- SQL
- AWS
- Relocation assistance
Senior Software Engineer - Ireland/Remote (m/f/x)*
Solventum —Dublin, County Dublin
- Full-time
- Computer Science
- Java
- AWS
- Relocation assistance
14d
Senior Manager, Core Labelling Strategy (12 month agency contract)
Viatris —Northern Cross, County Dublin
- Full-time
- Management
- Doctoral degree
- Master's degree
Care Manager Lead
Dovida Ireland —Dublin, County Dublin
- Full-time
- Nursing
- No degree
Clinical Specialist - Cardiac Rhythm Management
Abbott Laboratories —Dublin, County Dublin
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
22h
Project Manager - Installation & Digital Health Projects
Cardiac Services IRL —Dublin, County Dublin
- Full-time
- Engineering
- Project management
- IT
Quick apply
7d
Clinical Nurse Manager 3
Leopardstown Park Hospital —Foxrock, County Dublin
- €72,146–€81,478 a year
- Full-time
- Nursing
- Nursing
Quick apply
Account Manager
Eurofins Ireland Clinical Diagnostics —DUBLIN 18, County Dublin
- Full-time
- Hybrid work
- No degree
- Organisational skills
- Employee assistance program
- Sick pay
Quick apply
7d
Client Partner, Strategy Consulting Large Pharma Advisory, 1 year contract
IQVIA —Dublin, County Dublin
- Full-time
- Sales
- Organisational skills
- Communication skills
4d
Senior Cloud Engineer (m/f/x)*
Solventum —Dublin, County Dublin
- Full-time
- Azure
- Computer Science
- English
Business Development Manager - Expert Ecosystem
IQVIA —Dublin, County Dublin
- Full-time
- Business development
- Negotiation
2d
Senior Software Development Engineer (m/f/x)*
Solventum —Dublin, County Dublin
- Full-time
- Azure
- AWS
- Bachelor's degree
Director, FSA Project Management
ICON Plc —Dublin, County Dublin
- Full-time
- Analysis skills
- Project management
- Bachelor's degree
6d
Clinical Specialist Physiotherapist - Pectus Service
Beacon Hospital —Dublin, County Dublin
- Part-time
- Research
- Leadership
Quick apply
Clinical Specialist Physiotherapist, Outpatient Oncology Care (FTC)
Beacon Hospital —Dublin, County Dublin
- Full-time
- Leadership
Quick apply
Senior Medical / Biomedical Scientist– Haematology
Eurofins Ireland Clinical Diagnostics —Dublin, County Dublin
- Full-time
- Master's degree
- Bachelor's degree
- Communication skills
- Employee assistance program
- Sick pay
Quick apply
5h
Sr Specialist - AI Operations
Bristol-Myers Squibb —Dublin, County Dublin
- Full-time
- Microsoft Excel
- Azure
- Computer Science
- Annual leave
- Work from home
6d
Associate Director/Director, Patient and Site Centric Solutions, GTM & Solution Strategy
IQVIA —Dublin, County Dublin
- Full-time
- Business development
- Bachelor's degree
- No degree
4d
Head of Housekeeping
Mater Private Network —Dublin, County Dublin
- Full-time
- Cleaning
- Negotiation
Quick apply

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Senior Risk Management Engineer / Scientist

Viatris -
Northern Cross, County Dublin

Apply Now

Job details

Full-time

Qualifications

Analysis skills
Communication skills

Full job description

McDermott Laboratories Limited

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

Our Global Device Development organization is an innovative, technically strong, and fully integrated team focused on delivering high-quality, safe, and effective device and combination products to meet evolving patient healthcare needs worldwide. It provides leadership, strategic oversight, direction, support, and hands-on training for medical devices and combination products. Through thorough knowledge, this role will support the establishment, maintenance and remediation of risk management files for combination products and devices under development, on-market or acquired. A key focus of this role shall include critical engagement with on-market stakeholders including Quality, Clinical, and Pharmacovigilance to support the monitoring of product performance and safety

Every day, we rise to the challenge to make a difference and here’s how the Senior Risk Management Engineer/ Scientist role will make an impact:

Key responsibilities for this role include:

Be responsible for combination product / device Risk Management (RM) process implementation and thought leadership, to ensure the strategic development of Risk Management Files (RMFs), to meet the intended global business needs, in compliance with relevant regulations, standards, guidance and procedures.
Lead within the GDD Risk Management function, taking responsibility for developing and delivering subject matter expertise to cross-functional teams across the full device lifecycle, including global regulatory submissions, product launch, and post-market support
Seek to identify and lead the implementation of process improvements across GDD’s processes, to ensure high quality, efficient program delivery.
Within RM group, lead and contribute to, the development of RM principles, and associated processes and procedures, to ensure that GDD operates with the latest RM practices to ensure State of the Art (SOTA).
Under assigned design and development programs, lead Device Program Teams (DPTs) in the development of Risk Management File deliverables including, but not limited to, Failure Mode Effects Analysis (FMEA), Fault Tree Analysis, Medical Hazard Lists, and clinical trial preparation, against the defined design control / design and development timelines.
Contribute to regulatory submissions, regulatory responses, and external/ third party audits as required by the organization.
Assess Risk Management Files (RMFs) against on-market data and apply risk-based thinking to post-market sustaining activities to maintain the RMF’s contemporaneousness.
Collaborate with Device Development colleagues, Product Quality Oversight, Clinicians and Pharmacovigilance teams, through application of RM throughout the product Life-Cycle process to analyse, evaluate, mitigate and control risks, in line with International Standards, Regulatory requirements and local Quality Management System (QMS).
Lead and support the assessment of Change Controls (CC), Complaint Investigations, CAPAs and Quality Incidents, as applicable.
Communicate clearly and in a timely manner to program teams and within the functional line team to ensure potential and theoretical risks are identified and communicated in a constructive and timely manner.
Maintain detailed awareness and understanding of global risk management requirements for medical devices and drug-device combination products in regions of interest to the Viatris portfolio
Collaborate as part of “One Team”, with a common purpose of delivering high quality device / combination products, that are safe and effective for users

The minimum qualifications for this role are:

Degree with proven direct experience, in a regulated Pharma/Medical Device/ GMP environment.
A team player willing to support any other organisational needs/activities outside primary expertise to continuously develop the business
Ability to work independently and with minimal direction
Ability to define, organize, and manage individual and team tasks
Excellent communication and collaborative skills to lead or facilitate effective discussions. Able to communicate technical information to key stakeholders.
Experienced in design and development (ISO 13495 / 21CFR 820.) and Risk Management (ISO 14971:2019)
Familiarity with new product introduction/ development (NPI)/ NPD) and/ or Lifecycle Management / Sustaining
Demonstrable ability to execute to program deliverables and timelines
Strong problem solving and analytical skills
Detail-orientated without compromising on project timelines
Demonstrable understanding and application of the fundamental principles of Medical Device Risk Management within the regulatory framework of FDA 21 CFR 820.30 and EUMDR 2017/745
Demonstrable understanding and application of Design, Use and Manufacture risk-related analysis methodologies, including but not limited to FMEAs, FTAs and Medical Hazard Analysis

At Viatris, we offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to help make an impact on the lives of others.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

Apply Now

Refine Your Search

senior clinical data jobs in tallaght county dublin

Senior Risk Management Engineer / Scientist

Senior Software Development Engineer

Senior Software Engineer - Ireland/Remote (m/f/x)*

Senior Manager, Core Labelling Strategy (12 month agency contract)

Care Manager Lead

Clinical Specialist - Cardiac Rhythm Management

Project Manager - Installation & Digital Health Projects

Clinical Nurse Manager 3

Account Manager

Client Partner, Strategy Consulting Large Pharma Advisory, 1 year contract

Senior Cloud Engineer (m/f/x)*

Business Development Manager - Expert Ecosystem

Senior Software Development Engineer (m/f/x)*

Director, FSA Project Management

Clinical Specialist Physiotherapist - Pectus Service

Clinical Specialist Physiotherapist, Outpatient Oncology Care (FTC)

Senior Medical / Biomedical Scientist– Haematology

Sr Specialist - AI Operations

Associate Director/Director, Patient and Site Centric Solutions, GTM & Solution Strategy

Head of Housekeeping

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