Post-Market Surveillance Writer

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