Medical Writer

Pulse Biosciences Inc

Remote, US
Remote
5+ years medical writing experience
Clinical evaluation reports cer authoring
Iso 14155 and eu mdr knowledge
The role involves developing and maintaining clinical and regulatory documents such as Clinical Evaluation Reports and Investigator's Brochures to ensure compliance with global standards

Job Summary

  • The role involves developing and maintaining clinical and regulatory documents such as Clinical Evaluation Reports and Investigator's Brochures to ensure compliance with global standards.
  • Candidates must possess strong knowledge of clinical research methodologies and regulatory requirements including ISO 14155, EU MDR, and FDA guidance.
  • The company offers a dynamic startup-like environment with comprehensive benefits including stock options, flexible work schedules, and opportunities for professional growth.

Matching Summary

The role involves developing and maintaining clinical and regulatory documents such as Clinical Evaluation Reports and Investigator's Brochures to ensure compliance with global standards.

Skills & Requirements

Must-have

  • 5+ years medical writing experience
  • Clinical Evaluation Reports CER authoring
  • ISO 14155 and EU MDR knowledge
  • FDA submission support experience
  • Literature review and data synthesis

Nice-to-have

  • Knowledge of additional languages
  • Experience with notified body queries
  • Proficiency in database tools like PubMed
  • Ability to work with minimal direction
  • Strong attention to detail

Key Requirements

  • BS in Life Sciences or related field
  • 5+ years medical device writing experience
  • 7+ years general technical writing experience
  • Experience supporting FDA submissions
  • Proficiency in Microsoft Office Suite

Work Rights

Not specified

Tailored Resume

Cover Letter