Find Senior software Jobs in Spiddal, G

Senior Regulatory Affairs Specialist
Boston Scientific —Galway, County Galway
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
4d
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
Intermediate / Senior Civil Design Engineer, Galway
O'Connor Sutton Cronin —Galway, County Galway
- Holidays
- Hybrid work
- Microsoft Word
- AutoCAD
- Microsoft Excel
- Life insurance
Senior Site Reliability Engineer
Cisco Systems —Galway, County Galway
- Full-time
- Hybrid work
- Computer Science
- Bachelor's degree
- Software development
5d
Senior Opto-Mechanical Design Engineer
MBRYONICS —Galway, County Galway
- Full-time
- CAD
- Engineering
- Research
Clerical Officer with Fluency in Irish
Local Government Jobs Ireland —Galway, County Galway
- €31,935–€49,413 a year
- Customer service
- Administrative experience
- IT
9d
Thermal Engineer
MBRYONICS —Galway, County Galway
- Full-time
- Doctoral degree
- Engineering
- Master's degree
AI Operations Security Engineer
Cisco Systems —Galway, County Galway
- Full-time
- Doctoral degree
- Master's degree
- Bachelor's degree
Development Infrastructure Engineer (Civil)
AECOM —Galway, County Galway
- Full-time
- Hybrid work
- AutoCAD
Lead Contract Manager (Spanish & Italian speaker)
HubSpot —Galway, County Galway
- Remote
- Spanish
- English
- Mentoring
Quick apply
Associate Director - Electrical
EDC Engineering Design Consultants LTD. —Galway, County Galway
- Overtime
- Hybrid work
- Master's degree
- Team management
- Electrical Engineering
- Annual leave
- Work from home
Quick apply
Project Manager
JJ Rhatigan Building Contractors —Galway, County Galway
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
Senior Manager, Solutions Marketing
Diligent Corporation —Galway, County Galway
- Presentation skills
- AI
- Communication skills
- Annual leave
Quick apply
Software Engineering Manager
Datavant Ireland —Galway, County Galway
- On call
- Communication skills
Quick apply
Senior Product Manager, Interoperability
Datavant Ireland —Galway, County Galway
- Remote
- Project management
- Product management
Quick apply
Customer Advocate (French Speaking)
ASSA ABLOY —Galway, County Galway
- Full-time
- Microsoft Powerpoint
- Microsoft Excel
- Oracle
- Annual leave
Senior Solutions Architect
HubSpot —Galway, County Galway
- €67,200–€97,400 a year
- Remote
- Spanish
- Presentation skills
- Communication skills
Quick apply
13d
Sr.Data Engineer_10+ Years (Oracle, PL/SQL, Snowflake)- Galway,Ireland
Photon —Galway, County Galway
- Full-time
- Azure
- Oracle
- Computer Science
Implementation Engineer
Poppulo —Galway, County Galway
- €35,000–€50,000 a year
- Windows
- Communication skills
- Life insurance
Quick apply
3d
EMEA Customer Success Specialist - French Speaking
MathWorks —Galway, County Galway
- Doctoral degree
- Sales
- Social media management

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Senior Regulatory Affairs Specialist

Boston Scientific -
Galway, County Galway

Apply Now

Job details

4 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 spiddal, g

Senior Regulatory Affairs Specialist

Associate Mechanical Engineer

Intermediate / Senior Civil Design Engineer, Galway

Senior Site Reliability Engineer

Senior Opto-Mechanical Design Engineer

Clerical Officer with Fluency in Irish

Thermal Engineer

AI Operations Security Engineer

Development Infrastructure Engineer (Civil)

Lead Contract Manager (Spanish & Italian speaker)

Associate Director - Electrical

Project Manager

Senior Manager, Solutions Marketing

Software Engineering Manager

Senior Product Manager, Interoperability

Customer Advocate (French Speaking)

Senior Solutions Architect

Sr.Data Engineer_10+ Years (Oracle, PL/SQL, Snowflake)- Galway,Ireland

Implementation Engineer

EMEA Customer Success Specialist - French Speaking

I want to receive the latest job alerts for senior software in spiddal, g

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