PSUR Writer II

CooperCompanies

. Author and maintain PMS documentation including PMSPs, PMSRs, and PSURs for assigned product portfolios .

Posted 10/13/2026full-timeRemote • Connecticut • United StatesMid-LevelSenior💰 $75,000 - $100,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in post-market surveillance documentation, including PMSPs, PMSRs, and PSURs, while ensuring compliance with EU MDR and FDA regulations. Proficient in data analysis and quality management systems to support regulatory submissions and improve documentation processes.

Highest-signal resume keywords

Post-Market Surveillance DocumentationEU MDR ComplianceData AnalysisQuality Management SystemsRegulatory Affairs Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PMS DocumentationRegulatory ComplianceData CollectionTrend AnalysisDocument Review

Soft Skills

Strong Communication SkillsOrganizational SkillsDetail-OrientedTime-Management SkillsCross-Functional Team Collaboration

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft TeamsSharePoint

Industry Keywords

Quality AssurancePharmacovigilanceMedical WritingMedical Device RegulationsAdverse Event Reporting

About the role

Key responsibilities & impact

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
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

Requirements

What you’ll need

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
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
Bachelor's degree required in a scientific, technical, engineering, healthcare, or related discipline
Prolonged periods of sitting, especially in front of a computer
Position may require 0-5% domestic and/or international travel

Benefits

Comp & perks

Medical coverage
401(k)
Parental leave
Fertility benefits
Paid time off for vacation, personal, sick and holidays
Multiple other perks and benefits
Potential eligibility for other types of compensation and benefits