Find Sr. software Jobs in Tulla, Ce

Senior Regulatory Affairs Specialist
Boston Scientific —Galway, County Galway
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
11d
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 Opto-Mechanical Design Engineer
MBRYONICS —Galway, County Galway
- Full-time
- CAD
- Engineering
- Research
Senior Site Reliability Engineer
Cisco Systems —Galway, County Galway
- Full-time
- Hybrid work
- Computer Science
- Bachelor's degree
- Software development
12d
Senior Observability Engineer
Rent the Runway —Galway, County Galway
- On call
- DevOps
- Annual leave
Sr.Data Engineer_10+ Years (Oracle, PL/SQL, Snowflake)- Galway,Ireland
Photon —Galway, County Galway
- Full-time
- Azure
- Oracle
- Computer Science
Senior Engineer I
Merit Medical Systems Inc. —Galway, County Galway
- Full-time
- Doctoral degree
- Word processing
- Engineering
- Free parking
AI Operations Security Engineer
Cisco Systems —Galway, County Galway
- Full-time
- Doctoral degree
- Master's degree
- Bachelor's degree
Principal Software Engineer - MLOps
Liberty IT —Galway, County Galway
- Hybrid work
- AWS
- IT
- SDLC
- Employee discount
Senior Software Developer
AMCS Group —Galway, County Galway
- Full-time
- Hybrid work
- Computer Science
- Bachelor's degree
- JavaScript
Quick apply
3d
Site Engineer
NFT Logistics —Galway, County Galway
- €34,992.54–€84,568.41 a year
- Full-time
- Engineering
- Microsoft Office
- Construction experience
Quick apply
Senior Linux Kernel Engineer
MBRYONICS —Galway, County Galway
- Full-time
- Doctoral degree
- Computer Science
- Master's degree
Customer Support Specialist (+Portuguese Speaking)
Diligent Corporation —Galway, County Galway
- Weekend availability
- Hybrid work
- Customer service
- Salesforce
- English
- Annual leave
Quick apply
Senior Software Engineer, Core Experiences - Galway, Ireland
Speechify —Galway, County Galway
- €30,000–€120,000 a year
- Remote
- Java
6d
Senior Software Engineer, Windows/Desktop Applications - Galway, Ireland
Speechify —Galway, County Galway
- €30,000–€120,000 a year
- Remote
- Doctoral degree
- Windows
- C++
6d
Senior Electrical Design Engineer
Glanua —Galway, County Galway
- Full-time
- Microsoft Office
- Presentation skills
- IT
- Annual leave
- Employee assistance program
Quick apply
Analytics Engineer
CitySwift —Galway, County Galway
- Hybrid work
- Computer Science
- SQL
- No degree
- Annual leave
- Life insurance
Quick apply
Senior Geotechnical Engineer
Ayesa —Galway, County Galway
- Hybrid work
- Master's degree
- Presentation skills
- Civil Engineering
- Annual leave
- Employee assistance program
Quick apply
4d
Thermal Engineer
MBRYONICS —Galway, County Galway
- Full-time
- Doctoral degree
- Engineering
- Master's degree
Project Manager REF: 2617d
Fingleton White —Galway, County Galway
- Full-time
- Hybrid work
- Engineering
- English
- Microsoft Office
- Employee assistance program
Quick apply

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Senior Regulatory Affairs Specialist

Boston Scientific -
Galway, County Galway

Apply Now

Job details

11 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

sr. software jobs in tulla, ce

Senior Regulatory Affairs Specialist

Branch Manager

Senior Opto-Mechanical Design Engineer

Senior Site Reliability Engineer

Senior Observability Engineer

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

Senior Engineer I

AI Operations Security Engineer

Principal Software Engineer - MLOps

Senior Software Developer

Site Engineer

Senior Linux Kernel Engineer

Customer Support Specialist (+Portuguese Speaking)

Senior Software Engineer, Core Experiences - Galway, Ireland

Senior Software Engineer, Windows/Desktop Applications - Galway, Ireland

Senior Electrical Design Engineer

Analytics Engineer

Senior Geotechnical Engineer

Thermal Engineer

Project Manager REF: 2617d

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