Senior Medical Writer

Job Summary

To support regulatory approval efforts for medical devices, the full-time remote Senior Medical Writer will manage the creation and review of clinical regulatory documents, including Clinical Evaluation Plans and Post-Market Surveillance reports, while collaborating with cross-functional teams to ensure compliance with global regulatory requirements.

Key responsibilities

• Conduct systematic literature searches and synthesize information for clinical regulatory document creation
• Write, edit, and proofread various clinical regulatory documents in accordance with regulatory requirements
• Collaborate with cross-functional teams to prepare high-quality submission-ready clinical documentation

Required qualifications

• Bachelor's degree in Life Science, Biological Science, or related discipline
• 5 years of relevant experience in clinical medical writing within the life science industry
• Experience with EU MDR/MDD regulations