Find Senior software Jobs in Ballyvaughan, Ce

Senior Regulatory Affairs Specialist
Boston Scientific —Galway, County Galway
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
6d
Senior Linux Kernel Engineer
MBRYONICS —Galway, County Galway
- Full-time
- Doctoral degree
- Computer Science
- Master's degree
Sr. Director & Head of Architecture
G-P —Galway, County Galway
- €160,800–€201,000 a year
- Full-time
- Remote
- Computer Science
- Master's degree
- AWS
Quick apply
Senior Observability Engineer
Rent the Runway —Galway, County Galway
- On call
- DevOps
- Annual leave
Commercial Property Manager
Comer Group Ireland —Galway, County Galway
- Full-time
- Microsoft Office
- Organisational skills
- IT
- Free parking
Quick apply
BMS Design Engineer
Sygma Automation —Galway, County Galway
- Full-time
- Hybrid work
- CAD
- No degree
- Organisational skills
Quick apply
12d
Senior Data Engineer
Datavant Ireland —Galway, County Galway
- Remote
- Azure
- SQL
- AWS
Quick apply
Technical Lead - Database
Planet —Galway, County Galway
- Full-time
- Hybrid work
- Azure
- Oracle
- Computer Science
12h
Project Manager REF: 2617d
Fingleton White —Galway, County Galway
- Full-time
- Hybrid work
- Engineering
- English
- Microsoft Office
- Employee assistance program
Quick apply
Branch Manager
Synergy Security Solutions —Galway, County Galway
- €55,000 a year
- Weekend availability
- Management
- No degree
- Communication skills
- Employee assistance program
- Referral programme
Senior Systems Engineer - ACM
Medtronic —Galway, County Galway
- €64,640–€96,960 a year
- Full-time
- Engineering
- Analysis skills
- Bachelor's degree
16h
Associate Mechanical Engineer
EDC Engineering Design Consultants LTD. —Galway, County Galway
- Overtime
- Hybrid work
- Engineering
- Microsoft Office
- Master's degree
- Annual leave
- Work from home
Quick apply
Senior Site Reliability Engineer
Cisco Systems —Galway, County Galway
- Full-time
- Hybrid work
- Computer Science
- Bachelor's degree
- Software development
7d
Intermediate / Senior Civil Design Engineer, Galway
O'Connor Sutton Cronin —Galway, County Galway
- Holidays
- Hybrid work
- Microsoft Word
- AutoCAD
- Microsoft Excel
- Life insurance
Clerical Officer with Fluency in Irish
Local Government Jobs Ireland —Galway, County Galway
- €31,935–€49,413 a year
- Customer service
- Administrative experience
- IT
11d
Senior Opto-Mechanical Design Engineer
MBRYONICS —Galway, County Galway
- Full-time
- CAD
- Engineering
- Research
Thermal Engineer
MBRYONICS —Galway, County Galway
- Full-time
- Doctoral degree
- Engineering
- Master's degree
Development Infrastructure Engineer (Civil)
AECOM —Galway, County Galway
- Full-time
- Hybrid work
- AutoCAD
AI Operations Security Engineer
Cisco Systems —Galway, County Galway
- Full-time
- Doctoral degree
- Master's degree
- Bachelor's degree
Lead Contract Manager (Spanish & Italian speaker)
HubSpot —Galway, County Galway
- Remote
- Spanish
- English
- Mentoring
Quick apply

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Senior Regulatory Affairs Specialist

Boston Scientific -
Galway, County Galway

Apply Now

Job details

6 days ago

Qualifications

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Engineering
Research
Analysis skills
Bachelor's degree
Product development
Technical writing
Computer skills
Communication skills
Adobe Acrobat

Full job description

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Advancing possibilities for a brighter tomorrow

We are seeking a Senior Regulatory Affairs Specialist on a permanent basis to join our team. This role can be based out of any of the following sites: Ireland-Galway; Ireland-Clonmel; Ireland-Cork; US-MN-Maple Grove

About the role

Join our Vascular Therapies Team, where we create innovative technologies to diagnose and treat peripheral vascular disease. Our products improve patient outcomes and enhance lives by providing the most advanced and broadest set of therapy solutions.

The Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews.

Your responsibilities will include:

Support the development of domestic and international strategies for Class II and III medical devices
Represent RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations
Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR
Support international geographies to gain and maintain product approvals
Support efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing
Supporting regulatory audits, as required

Required Qualifications:

Level 8 Hons Bachelor Degree (or higher) in Engineering or related field
4+ years Regulatory Affairs or related discipline in medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling, etc)
Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as US 510(k)s and EU MDR technical documentation
Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
Previous experience supporting medical electrical equipment
General understanding of product development process and design controls
Working knowledge of US FDA, EU, and international regulations
Ability to manage several projects
Effective research and analytical skills
Effective written and oral communication, technical writing and editing skills
Works well in fast-paced cross-functional team environments
Team player with excellent interpersonal skills

At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email [email protected].

Apply Now

Refine Your Search

senior software jobs in ballyvaughan, ce

Senior Regulatory Affairs Specialist

Senior Linux Kernel Engineer

Sr. Director & Head of Architecture

Senior Observability Engineer

Commercial Property Manager

BMS Design Engineer

Senior Data Engineer

Technical Lead - Database

Project Manager REF: 2617d

Branch Manager

Senior Systems Engineer - ACM

Associate Mechanical Engineer

Senior Site Reliability Engineer

Intermediate / Senior Civil Design Engineer, Galway

Clerical Officer with Fluency in Irish

Senior Opto-Mechanical Design Engineer

Thermal Engineer

Development Infrastructure Engineer (Civil)

AI Operations Security Engineer

Lead Contract Manager (Spanish & Italian speaker)

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