PSUR Writer II

Cooper Surgical 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 Cooper Companies, 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 womens 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

Cooper Surgical 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 Cooper Companies, 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 womens 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

Remote in US

The PSUR Writer II is responsible for the preparation, maintenance, and timely completion of Post-Market Surveillance Plans (PMSPs), Post-Market Surveillance Reports (PMSRs), and Periodic Safety Update Reports (PSURs) to ensure compliance with global regulatory requirements. The role collaborates cross-functionally to gather relevant safety, clinical, complaint, vigilance, and risk management information; evaluates and summarizes data; and ensures documentation is completed in accordance with applicable regulatory requirements and internal timelines.

The PSUR Writer II contributes to process improvements, supports the development of departmental procedures and templates, and serves as a knowledgeable resource for post-market surveillance documentation activities.

• Author and maintain PMS documentation including PMSPs, PMSRs, and PSURs for assigned product portfolios.
• Gather and compile information from Clinical Affairs, Regulatory Affairs, Risk Management, Marketing, Quality, and other stakeholders.
• Analyze and summarize post-market surveillance, complaint, vigilance, clinical, and risk management data to develop regulatory-compliant safety summaries and trend analyses.
• Support literature reviews and post-market surveillance activities.
• Conduct public database searches for adverse events, recalls, and competitor safety information.
• Perform data collection, quality checks, and basic analysis to support PSUR development.
• Review, trend, and analyze relevant safety and performance data to support conclusions documented within PMSRs and PSURs.
• Maintain documentation within the Quality Management System.
• Proactively identify potential timeline, quality, or data risks affecting assigned reports and communicate mitigation plans to management.
• Contribute to the development, maintenance, and continuous improvement of PMS and PSUR-related procedures, work instructions, templates, and guidance documents.
• Identify opportunities to improve document quality, consistency, and efficiency within PMS reporting processes.
• Ensure documentation is maintained in accordance with Quality Management System requirements and current regulatory expectations.
• Support EU MDR compliance activities related to PMS documentation.
• Participate in cross-functional meetings and project discussions.
• Perform other duties as assigned.

This position may require 0-5% domestic and/or international travel.

• Strong written and verbal communication skills.
• Basic understanding of EU MDR, FDA regulations, and medical device vigilance requirements.
• Ability to summarize technical and scientific information clearly.
• Strong organizational and time-management skills.
• Detail-oriented with strong document review capabilities.
• Proficiency with Microsoft Word, Excel,…