高级PSUR撰写员
Senior PSUR Writer
关于CooperSurgical
CooperSurgical是一家领先的生育和女性健康公司，致力于在生命中最重要的医疗时刻为女性、婴儿和家庭争取时间。作为CooperCompanies的一个部门，我们以统一的宗旨驱动，帮助患者体验生命中的美好时刻。我们秉持共同的价值观——专注、创新、友好、协作和做正确的事，我们的产品支持患者终身的健康需求，从避孕到生育和分娩解决方案，再到女性和家庭护理，以及更广泛的领域。我们目前为医疗提供者提供超过600种临床相关的医疗器械，包括检测和治疗方案，以及创新的辅助生殖技术和基因组检测解决方案。了解更多，请访问。
工作地点：美国远程办公
职位概述：
高级PSUR撰写员负责主导全球医疗器械组合的上市后监测计划（PMSP）、上市后监测报告（PMSR）和定期安全更新报告（PSUR）的开发、审查和提交准备。该职位是上市后监测文档和监管要求的专家，就安全趋势和风险获益评估提供战略建议，并支持初级撰写人员，同时确保及时符合国内外法规。
最初发布于Himalayas
查看英文原文
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.
Originally posted on Himalayas