Boston Scientific Regulatory Affairs International Support Specialist II 

Costa Rica, Heredia 

789962731

Jennifer Amy Mardones TschidaRecruiter:Jose Daniel Calderon Robles

Hybrid Roles:

About this role:

With adequate supervision, the is responsible for supporting international geographies to gain and maintain EP product approvals.

Your responsibilities will include:

• Prepare and provide appropriate documentation to international Regulatory partners for new product registrations and renewals.
• Prepare and provide appropriate documentation to international Regulatory partners to support change submissions.
• Support international requests for product release in collaboration with Division Regulatory product SME.
• Liaise with international Regulatory partners for various projects as directed.
• Support efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing.

What we’re looking for in you:

Minimum Qualifications

• Bachelor’s degree, minimum
• 2-3 years of experience in Regulatory Affairs (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in the medical device industry
• Proven organizational skills, including ability to manage multiple tasks/requests
• Basic computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
• English proficiency 90%+

Preferred Qualifications

• General understanding of product development process and design controls
• Working knowledge of FDA, EU and international regulations
• Effective problem solving skills
• Effective written and oral communication