Senior PSUR Writer

📋 Description

• Lead the development, review, and submission readiness of Post-Market Surveillance Plans (PMSPs)
• Serve as a subject matter expert on post-market surveillance documentation, processes, and
• Provide strategic input into the evaluation of safety trends, emerging issues, and benefit-risk
• Ensure surveillance documentation is accurate, consistent, scientifically sound, and aligned with
• Collaborate with cross-functional stakeholders to gather, evaluate, and incorporate relevant
• Support timely preparation and review of regulatory documentation to maintain ongoing compliance

🎯 Requirements

• Demonstrated experience developing and reviewing post-market surveillance documentation within the
• Strong knowledge of Post-Market Surveillance Plans, Post-Market Surveillance Reports, Periodic
• Experience interpreting global regulatory expectations and applying them to medical device safety
• Strong understanding of safety trend analysis, risk-benefit evaluation, and post-market data
• Excellent technical and regulatory writing skills, with a strong ability to communicate complex
• Strong attention to detail and the ability to manage multiple regulatory deliverables while meeting

🎁 Benefits

• Fully remote position within the United States
• Opportunity to serve as a subject matter expert in global post-market surveillance
• Exposure to complex medical device portfolios and international regulatory requirements
• Opportunity to contribute directly to patient safety and ongoing product compliance
• Collaborative environment with opportunities to support and mentor other writers
• Strategic role combining regulatory writing, safety assessment, and global compliance activities