Boston Scientific Technical Writer II 

Costa Rica 

667509033

Costa Rica-Heredia

Hybrid Roles:

Your Responsibilities Include:

• Documentation Creation and Maintenance: Develop and maintain design history files (DHF), risk management file deliverables (e.g., Hazard Analysis, DFMEA), and other technical documents for interventional cardiology medical devices.
• Quality System and Regulatory Compliance: Help ensure that all documentation complies with:
  • Relevant Boston Scientific Quality System requirements and good documentation practices (GDP).
  • Relevant regulatory standards (e.g., FDA, ISO), and other global medical device regulations (e.g., MDR).
• Content Management: Manage the release and revision of version-controlled documents in the BSC document management system.
• Collaboration: Work closely with cross-functional teams including Regulatory Affairs, Research & Development, and Clinical Risk to gather information and ensure accuracy of technical content.
• Editing and Proofreading: Review and edit documentation for clarity, grammar, and style, ensuring consistency across all materials. Incorporate feedback from stakeholders to continuously improve documentation quality and usability.

What we're looking for:

• Education: Bachelor's degree in Technical Writing, English, Communications, Engineering, or a related field.
• Experience: Minimum of 2 years of experience in technical writing, preferably in the medical device industry.
• Language: Must be bilingual in Spanish and English with a strong command of the English language.
• Skills:
  • Excellent writing, editing, and proofreading skills.
  • Ability to manage multiple projects and meet deadlines.
  • Proficiency in document management systems and content creation tools.
  • Strong interpersonal and communication skills.
  • Attention to detail and a commitment to producing high-quality documentation.

• Previous experience working in a regulated environment.
• Working knowledge of medical device regulations and standards.
• Knowledge of medical terminology and clinical practices.