Senior PSUR Writer - Remote (US)

CooperSurgical, Inc.; Trumbull (CT); Teletrabalho; USD 120 000 - 150 000; Tempo integral

Resumo da oferta

CooperSurgical, Inc. is seeking a Sr. PSUR Writer to lead the development, review, and submission readiness of PMSPs, PMSRs, and PSURs for our global medical device portfolio. The role requires deep expertise in post-market surveillance documentation and regulatory requirements, with focus on safety trends and risk-benefit analyses.

You will support junior writers and ensure timely compliance with both domestic and international regulations while working remotely in the United States.

Responsabilidades

• 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, providing strategic input on safety trends and risk-benefit evaluations.
• Support junior writers while ensuring timely compliance with domestic and international regulations.

Descrição da oferta de emprego

CooperSurgical, Inc. is seeking a Sr. PSUR Writer to lead the development, review, and submission readiness of PMSPs, PMSRs, and PSURs for our global medical device portfolio. The role requires deep expertise in post-market surveillance documentation and regulatory requirements, with focus on safety trends and risk-benefit analyses.

You will support junior writers and ensure timely compliance with both domestic and international regulations while working remotely in the United States.