Post-Market Surveillance Writer

Job Summary

To ensure compliance with global regulatory requirements, the full-time remote Post-Market Surveillance Writer will prepare, maintain, and complete Post-Market Surveillance Plans, Reports, and Periodic Safety Update Reports while collaborating cross-functionally to gather and analyze relevant data.

Key responsibilities

• Author and maintain PMS documentation including PMSPs, PMSRs, and PSURs for assigned product portfolios
• Gather and compile information from various stakeholders such as Clinical Affairs, Regulatory Affairs, and Risk Management
• Analyze and summarize post-market surveillance data to develop regulatory-compliant safety summaries and trend analyses

Required qualifications

• Bachelor's degree in a scientific, technical, engineering, healthcare, or related discipline
• 3+ years of experience in Quality Assurance, Regulatory Affairs, Pharmacovigilance, Medical Writing, or related medical device functions
• Basic understanding of EU MDR, FDA regulations, and medical device vigilance requirements
• Experience supporting PMS Plans, PSURs, PMSRs, or related regulatory documents preferred
• Proficiency with Microsoft Word, Excel, Teams, and SharePoint