Regulatory Affairs Specialist II

Additional Locations: Costa Rica-Heredia

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.

About the Role: 

Boston Scientific (BSC) is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We are looking for a Regulatory Affairs Specialist II to work in our rapidly growing Peripheral Interventions Division. 

Your Responsibilities: 

• Cross functional collaboration and review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory submissions 
• Liaise with International BSC Regulatory Affairs colleagues on product and manufacturing changes to support information requests and international submissions 
• Support the coordination, writing, and submission of U.S. and EU regulatory submissions for modified products and manufacturing changes 
• Maintain EU MDR Technical Documentation  

• Represent RA on cross functional project teams 
• Participate in corporate and department training 

Minimum Requirements: 

• Minimum of a bachelor’s degree or related field
• 2+ years regulatory affairs or related experience  
• Ability to collaborate with cross-functional team members to gain understanding of technical information through thoughtful questioning and engagement with team members 
• Ability to communicate technical information and complex ideas clearly and succinctly both orally and in writing 
• Demonstrated ability to effectively manage multiple projects and priorities and execute in a timeline driven environment 
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat 
• Advance English Level 

Requisition ID: 603398

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 (NYSE: BSX) 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!