Senior PSUR Writer - Remote (US) Regulatory Lead

CooperSurgical; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

CooperSurgical in the United States is seeking a Sr. PSUR Writer to lead the development, review, and submission readiness of PMSPs, PMSRs, and PSURs for global medical device portfolios.

The role requires expertise in post-market surveillance documentation and regulatory requirements, with a focus on safety trends and risk-benefit analyses. You will act as a subject matter expert, support junior writers, and ensure timely compliance with domestic and international regulations in a remote-work

Responsibilities

• Lead the development, review, and submission readiness of Post-Market Surveillance Plans (PMSPs), Post-Market Surveillance Reports (PMSRs), and Periodic Safety Update Reports (PSURs) for global medical device portfolios.
• Serve as a subject matter expert in post-market surveillance documentation and regulatory requirements, provide strategic input on safety trends and risk-benefit evaluations, and support junior writers while ensuring timely compliance.

Job description

CooperSurgical in the United States is seeking a Sr. PSUR Writer to lead the development, review, and submission readiness of PMSPs, PMSRs, and PSURs for global medical device portfolios.

The role requires expertise in post-market surveillance documentation and regulatory requirements, with a focus on safety trends and risk-benefit analyses. You will act as a subject matter expert, support junior writers, and ensure timely compliance with domestic and international regulations in a remote-work