Senior PSUR Writer

CooperSurgical; United States; On-site; 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

About CooperSurgical

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at .

Work location: Remote in US

Job Summary

The Sr. PSUR Writer is responsible for leading 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. This role serves as a subject matter expert in post-market surveillance documentation and regulatory requirements, provides strategic input regarding safety trends and risk-benefit evaluations, and supports junior writers while ensuring timely compliance with domestic and international regulations.