PSUR Writer II
About The Position
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.
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.
- Bachelor's degree required in a scientific, technical, engineering, healthcare, or related discipline.
Nice To Haves
- Experience supporting PMS Plans, PSURs, PMSRs, CERs, or related regulatory documents preferred.
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.
Benefits
- medical coverage
- 401(k)
- parental leave
- fertility benefits
- paid time off for vacation, personal, sick and holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
