Senior PSUR Writer

CooperSurgical, Inc.; Trumbull (CT); Remote; USD 120.000 - 150.000; Vollzeit

Zusammenfassung

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.

Aufgaben

• 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.

Jobbeschreibung

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 www.coopersurgical.com .

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.

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 www.coopersurgical.com. Work location: Remote in US