Senior Medical Writer

Job Summary

A company is looking for a Senior Medical Writer responsible for developing and managing clinical and regulatory documents.

Key Responsibilities

• Author and edit clinical documents, including Clinical Evaluation Reports (CERs) and regulatory submissions
• Plan and report clinical data collection for Post-Market Clinical Follow-up (PMCF) and clinical trials
• Ensure compliance of clinical documentation with EU MDR, FDA, and international regulatory requirements

Required Qualifications

• Strong understanding of EU MDR, FDA regulations, and ISO standards for medical devices
• Preferred 5-10 years of experience in medical writing for medical devices
• Master's degree in Life Sciences or related field preferred
• Proficiency in document management systems and Microsoft Office Suite
• Analytical mindset and organized approach to work