Regulatory Affairs Specialist, P3

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

Boston Scientific is seeking a highly motivated Regulatory Affairs Specialist III on a permanent basis to join our team.

In the Interventional Oncology and Embolization (IO&E) division we offer the broadest portfolio of solutions enabling physicians to minimally invasively treat tumours by delivering targeted and localized embolic and ablative technologies. We continue to innovate in key areas and extend our products into new geographies and high-growth adjacency markets. 
 
About this role: 

This is a hybrid position (in office minimum three days per week) located at the Cork or Galway Office. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

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: 

• Maintain EU MDR Technical Documentation and General Safety and Performance Requirements (GSPR) checklists to ensure ongoing regulatory compliance.


• Prepare and submit EU MDR Technical Documentation to Notified Bodies in accordance with sampling plan and recertification requirements.


• Partner with cross-functional teams to address and resolve deficiencies received from Notified Bodies during recertification and sampling plan reviews.


• Collaborate with Medical Safety, Clinical Risk, R&D, and Design Assurance to prepare and submit Periodic Safety Update Reports (PSURs) and Summaries of Safety and Clinical Performance (SSCPs) to Notified Bodies.


• Support operations and sustaining teams by conducting and documenting EU, US and international regulatory impact assessments for supplier, manufacturing, and product design changes.


• Provide support for regulatory audits and inspections, as required.


• Demonstrate a strong commitment to patient safety and product quality by ensuring compliance with the Quality Policy and all applicable quality systems, processes, and procedures in all activities

Required Qualifications:

• A minimum of a bachelor’s degree 


• A minimum of 5 years of EU and US medical device regulatory affairs experience


• Demonstrated experience assessing product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings


• Demonstrated experience authoring/supporting regulatory submissions for EU, such as MDR Technical Documentation and General Safety and Performance Requirements Checklist.


• 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 

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 [email protected]