Boston Scientific Regulatory Affairs Specialist II 

Costa Rica, Heredia 

435824237

Costa Rica-Heredia

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