Regulatory Medical Writer

Job Summary

A company is looking for a Regulatory Medical Writer-Ad Hoc.

Key Responsibilities:

• Author and manage regulatory documents such as Clinical Study Reports, protocols, Investigator Brochures, and Informed Consent Forms
• Ensure compliance with FDA, EMA, and ICH guidelines for all regulatory documents
• Collaborate with cross-functional teams to gather and verify source information and support medical device documentation

Required Qualifications:

• Bachelor's degree in life sciences or a related field with at least 5 years of medical writing experience
• Proven experience in writing regulatory documents including CSRs, protocols, and ICFs
• Familiarity with EU Medical Device Regulation and experience with MDR-compliant documentation
• Strong understanding of regulatory requirements and guidelines (FDA, EMA, ICH)