PSUR Writer
US$100,000 – US$130,000 / yr base salary
Posted 1 Oct 2026
Advertised as “Senior PSUR Writer”
BranchFactor Summary
The original posting with the fluff stripped out
- Expected experience
- 5+ yrs
- Management level
- People management
- Employment
- Remote
| Base salary | US$100,000 – US$130,000 / yr |
|---|
Field of studyEngineering, Healthcare, Science (or related)
Study levelBachelor's
Study levelMaster's or higher
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.
Responsibilities
-
Lead the authoring, review, and maintenance of PSURs, PMSPs, PMSRs, and related post-market surveillance documentation.
-
Independently manage multiple product families and report cycles simultaneously.
-
Interpret and analyze complaint, vigilance, clinical, literature, CAPA, trend, and risk management data to support safety assessments.
-
Develop comprehensive safety narratives, conclusions, and risk-benefit evaluations.
-
Serve as the primary cross-functional liaison for PSUR development activities.
-
Ensure compliance with EU MDR 2017/745, FDA requirements, ISO 13485, and ISO 14971 expectations.
-
Identify safety signals, emerging trends, and potential regulatory risks.
-
Provide recommendations regarding risk management file updates and surveillance strategies.
-
Lead the development, implementation, and maintenance of global procedures, work instructions, templates, and best practices related to Post-Market Surveillance Plans (PMSPs), Post-Market Surveillance Reports (PMSRs), and Periodic Safety Update Reports (PSURs).