Regulatory Affairs Specialist II

About the role

Boston Scientific is looking for a Regulatory Affairs Specialist II to join its Interventional Therapies Division. The role involves reviewing product and manufacturing changes for regulatory compliance and supporting regulatory submissions across the United States and Europe. The position is hybrid, combining working from home and onsite work.

Key responsibilities

• Collaborate cross-functionally and review product and manufacturing changes for compliance with applicable regulations and their impact on regulatory submissions
• Liaise with International 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 Regulatory Affairs on cross-functional project teams
• Participate in corporate and department training

Required profile

• Minimum of a bachelor's degree or in a related field
• 2+ years of regulatory affairs or related experience
• Ability to collaborate with cross-functional teams and understand technical information through thoughtful questioning
• Ability to communicate technical information and complex ideas clearly and succinctly, orally and in writing
• Ability to manage multiple projects and priorities in a timeline-driven environment
• Advanced English level

Required skills

• Basic submission and presentation-related computer skills
• Microsoft Word, Excel, PowerPoint and Adobe Acrobat