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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