PSUR Writer II

Job Description:

• 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:

• 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:

• 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