PSUR Writer II
CooperCompanies
Summary
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.
Job description
Responsibilities
- 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.
Travel: This position may require 0-5% domestic and/or international travel.
Qualifications
- 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, Teams, and SharePoint.
- Basic understanding of Quality Management Systems.
- Ability to work effectively in a cross-functional team environment.
Work Environment: Prolonged periods of sitting, especially in front of a computer.
Experience: 3+ years experience in Quality Assurance, Regulatory Affairs, Pharmacovigilance, Medical Writing, or related medical device functions. Experience supporting PMS Plans, PSURs, PMSRs, CERs, or related regulatory documents preferred.
Education: Bachelor's degree required in a scientific, technical, engineering, healthcare, or related discipline.
Requirements
- 3+ years experience in Quality Assurance, Regulatory Affairs, Pharmacovigilance, Medical Writing, or related medical device functions
- Bachelor's degree required in a scientific, technical, engineering, healthcare, or related discipline
- 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, Teams, and SharePoint
- Basic understanding of Quality Management Systems
- Ability to work effectively in a cross-functional team environment
- Experience supporting PMS Plans, PSURs, PMSRs, CERs, or related regulatory documents preferred
Benefits
- Medical coverage
- 401(k)
- Parental leave
- Fertility benefits
- Paid time off
- Vacation
- Personal leave
- Sick leave
- Holidays
Company overview
CooperCompanies (Nasdaq: COO) is a leading global medical device company headquartered in San Ramon, California, with a workforce of over 15,000 employees. The company operates through two primary business units: CooperVision and CooperSurgical. CooperVision is a trusted leader in the contact lens industry, focusing on vision correction and improving daily visual experiences for millions worldwide. CooperSurgical specializes in fertility and women's healthcare, providing innovative medical devices and solutions that support reproductive health and family planning. With products sold in over 130 countries, CooperCompanies positively impacts more than fifty million lives annually. The company generates approximately $4.1 billion in annual revenue and maintains a strong global presence, leveraging its expertise in medical device manufacturing to address critical healthcare needs in both vision care and women's health sectors. CooperCompanies is publicly traded and continues to expand its market leadership through strategic acquisitions, product innovation, and operational excellence.