Regulatory Affairs Specialist, P4

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

• Job Title: Regulatory Affairs Specialist, P4
• Location: Cork
• Work Mode: Hybrid
• Req Number: 623569
• Contract Type: Regular
• Reporting to: Associate Director, Reg Affairs
• Closing Date: Friday,  February 13th 2026

Apply through My Career Navigator attaching an updated CV.

IMPORTANT

You are required to inform your Supervisor/Manager of your application within 48 hours of applying. Please ensure that you meet the educational requirements for the role. Failure to do so may impact your application. 

At Boston Scientific, how we work is as important as what we achieve. All employees are expected to demonstrate the following core behaviours: 

Caring

• Act with integrity and do the right thing
• Listen with empathy and show compassion for patients, customers, communities, and colleagues

Diversity

• Respect different perspectives and experiences
• Actively include others and value unique ideas and backgrounds

Global Collaboration

• Create common purpose across teams and geographies
• Assume positive intent and work collaboratively to extend the reach of medical solutions

High Performance

• Deliver what matters and focus on meaningful outcomes
• Learn continuously, coach others, and strive for excellence to benefit patients, customers, shareholders, and employees

Meaningful Innovation

• Lean into change and embrace new ways of thinking
• Solve unmet needs by transforming ideas into breakthrough services and sustainable solutions

Winning Spirit

• Dare to try, take smart risks, and learn from experience
• Act with speed, agility, and accountability to continuously improve patient care

 
Your responsibilities will include: 

• Develop US, EU and international regulatory strategies for approval of medical devices
• Coordinate, compile, and submit U.S. and EU regulatory filings for new and modified products
• Support requests from BSC international regulatory personnel related to submissions, registrations, and change assessments
• Develop and maintain positive relationships with regulatory body reviewers 
• Review technical and labelling documentation for inclusion in regulatory filings
• Support operations and sustaining teams by conducting and documenting EU, US and international regulatory impact assessments for supplier, manufacturing, and product design changes.
• Represent RA on cross functional projects which may include product development, sustaining changes, and continuous improvement efforts
• Review clinical study protocols and other clinical documentation, and assess clinical study related changes to determine regulatory impact 
• Support regulatory audits, as required
• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Required Qualifications:

• A minimum of a Bachelor's Degree 
• A minimum of 8 years of regulatory affairs experience
• Demonstrated experience assessing product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as 510(k)s and MDR Technical Documentation
• Basic computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

• Strong technical, research and problem-solving skills
• Ability to articulate complex ideas clearly both verbally and in writing
• Team player with excellent interpersonal skills
• Demonstrated ability to effectively manage multiple projects and priorities
• Works well in fast-paced cross-functional team environments  

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 TalentAcquisitionIre@bsci.com.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

To search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers

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 TalentAcquisitionIre@bsci.com.