Expoint - all jobs in one place

Finding the best job has never been easier

Limitless High-tech career opportunities - Expoint

Boston Scientific Regulatory Affairs International Support Specialist II 
Costa Rica, Heredia 
789962731

05.07.2024

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