Take on a vital role as a Clinical Evaluation Medical Writer ensuring EU MDR compliance. Your expertise will directly affect the quality of regulatory and clinical documents.
This position requires a Medical Device Writer with 1-2 years of relevant experience. You will focus on authoring Clinical Evaluation Reports and supporting the regulatory submissions process. Your familiarity with EU regulations and standards will help in maintaining high-quality documentation and necessitates working across multiple teams.
Key Responsibilities:
• Author and edit Clinical Evaluation Reports and PMCF documents
• Collect and assess data from literature and clinical studies
• Collaborate with teams to ensure regulatory readiness
• Conduct literature searches for systematic reviews
• Assist with regulatory audits and Notified Body interactions
Requirements:
• Bachelor’s in Life Sciences, Biomedical Engineering
• 1-2 years in medical writing specific to devices
• Exper...