Senior PSUR Writer

Job Description

• This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior PSUR Writer based in United States. The Senior PSUR Writer plays a key role in ensuring the ongoing safety and regulatory compliance of global medical device portfolios. This position leads the development, review, and submission readiness of critical post-market surveillance documentation. You will serve as a subject matter expert on surveillance requirements and regulatory expectations across multiple markets. The role combines scientific and regulatory expertise with strategic assessment of emerging safety trends and benefit-risk considerations. You will work cross-functionally to support high-quality, timely submissions and maintain strong regulatory standards. The position also offers the opportunity to mentor junior writers and contribute to robust global post-market surveillance practices.
• Accountabilities: Lead the development, review, and submission readiness of Post-Market Surveillance Plans (PMSPs), Post-Market Surveillance Reports (PMSRs), and Periodic Safety Update Reports (PSURs). Serve as a subject matter expert on post-market surveillance documentation, processes, and applicable regulatory requirements. Provide strategic input into the evaluation of safety trends, emerging issues, and benefit-risk assessments across global medical device portfolios. Ensure surveillance documentation is accurate, consistent, scientifically sound, and aligned with applicable domestic and international regulations. Collaborate with cross-functional stakeholders to gather, evaluate, and incorporate relevant post-market safety and performance information. Support timely preparation and review of regulatory documentation to maintain ongoing compliance and submission readiness. Provide guidance and support to junior writers, helping strengthen documentation quality and post-market surveillance capabilities across the team. Requirements: Demonstrated experience developing and reviewing post-market surveillance documentation within the medical device industry. Strong knowledge of Post-Market Surveillance Plans, Post-Market Surveillance Reports, Periodic Safety Update Reports, and related regulatory requirements. Experience interpreting global regulatory expectations and applying them to medical device safety and surveillance activities. Strong understanding of safety trend analysis, risk-benefit evaluation, and post-market data assessment. Excellent technical and regulatory writing skills, with a strong ability to communicate complex information clearly and accurately. Strong attention to detail and the ability to manage multiple regulatory deliverables while meeting deadlines. Ability to work effectively with cross-functional teams and provide subject matter expertise to internal stakeholders. Experience mentoring or supporting junior regulatory or medical writers is highly desirable. Ability to work independently in a remote environment while maintaining strong collaboration and accountability. 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.
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