Find Senior risk management engineer / Jobs in Damastown County Dublin

Senior Risk Management Engineer / Scientist
Viatris —Northern Cross, County Dublin
- Full-time
- Analysis skills
- Communication skills
Senior Identity & Access Management (IAM) Engineer
Workday —Dublin, County Dublin
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Head of Product Management LIMS / LIS Clinical Diagnostics
Eurofins —Dublin, County Dublin
- Full-time
- Hybrid work
- Azure
- Analysis skills
- Continuous improvement
Quick apply
FS Technology Consulting - Senior Solution Architect - Senior Manager/Director - Dublin
EY —DUBLIN 2, County Dublin
- Full-time
- Hybrid work
- Computer Science
- DevOps
- Engineering
- Gym membership
10d
Senior Data Analyst (Investment Management)
Davy —Dublin, County Dublin
- Hybrid work
- Azure
- DevOps
- Data analysis skills
- Employee assistance program
Quick apply
Senior Engineer & Project Manager - Major Transportation Infrastructure Delivery, Roads & Public Transportation
AECOM —Dublin, County Dublin
- Full-time
- Hybrid work
- Engineering
- Project management
- No degree
Head of Professional Services
PFH Technology Group —Dublin, County Dublin
- Full-time
- Hybrid work
- Azure
- Management
Quick apply
AI Solution Architect - AWS Senior Manager - Data & AI - Technology Consulting - Advisory
PwC —Dublin, County Dublin
- Full-time
- Computer Science
- Engineering
- Master's degree
Senior Project Manager - Modular Solutions
CEL - Critical Power —Dublin, County Dublin
- Full-time
- English
- Project management
- Electrical Engineering
Quick apply
Senior Quality Engineer - Validation
West Pharmaceutical Services —Dublin, County Dublin
- €65,208–€82,992 a year
- Engineering
- Manufacturing
- Communication skills
QA Automation Engineer, Charles River Development, Senior Associate
State Street —Dublin, County Dublin
- Full-time
- Azure
- DevOps
- Java
Senior Risk Manager
AECOM —Dublin, County Dublin
- Hybrid work
- Business
- Communication skills
Senior Site Reliability engineer
Guidewire Software —Dublin, County Dublin
- Weekend availability
- Oracle
- Computer Science
- DevOps
Business Command Center Major and Cyber Incident Region Lead (SVP)
Citi —Dublin, County Dublin
- €119,760–€179,640 a year
- Full-time
- Hybrid work
- Master's degree
- Bachelor's degree
- Leadership
Asset Management Airport Asset Manager
DAA —Dublin, County Dublin
- Full-time
- AutoCAD
- Microsoft Office
- Construction experience
UKI Business Consulting - Capital Projects - Infrastructure Controls Specialist, All Levels
EY —DUBLIN 2, County Dublin
- Full-time
- Hybrid work
- Engineering
- Master's degree
- Analysis skills
- Gym membership
PMO Lead (FTC) REF: 2628b
Fingleton White —Dublin, County Dublin
- Hybrid work
- Microsoft Office
- Project management
- Communication skills
- Employee assistance program
Quick apply
Reporting Manager-Rail projects
AECOM —Dublin, County Dublin
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
AI Workplace (M365) & Microsoft Purview Senior Engineer
BearingPoint Ireland —Dublin, County Dublin
- Hybrid work
- SharePoint
- AI
- Communication skills

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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 risk management engineer / jobs in damastown county dublin

Senior Risk Management Engineer / Scientist

Senior Identity & Access Management (IAM) Engineer

Senior IT Lead and Delivery Manager

Head of Product Management LIMS / LIS Clinical Diagnostics

FS Technology Consulting - Senior Solution Architect - Senior Manager/Director - Dublin

Senior Data Analyst (Investment Management)

Senior Engineer & Project Manager - Major Transportation Infrastructure Delivery, Roads & Public Transportation

Head of Professional Services

AI Solution Architect - AWS Senior Manager - Data & AI - Technology Consulting - Advisory

Senior Project Manager - Modular Solutions

Senior Quality Engineer - Validation

QA Automation Engineer, Charles River Development, Senior Associate

Senior Risk Manager

Senior Site Reliability engineer

Business Command Center Major and Cyber Incident Region Lead (SVP)

Asset Management Airport Asset Manager

UKI Business Consulting - Capital Projects - Infrastructure Controls Specialist, All Levels

PMO Lead (FTC) REF: 2628b

Reporting Manager-Rail projects

AI Workplace (M365) & Microsoft Purview Senior Engineer

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