Remote PSUR Writer II - Post-Market Surveillance

CooperSurgical; Trumbull (CT); Remote; USD 75,000 - 100,000; Full time

Job summary

CooperSurgical is seeking a PSUR Writer II to prepare, maintain, and timely complete PMSPs, PMSRs, and PSURs, ensuring compliance with global regulatory requirements. You will gather data from Clinical, Regulatory, Risk, and Quality teams and summarize safety information for regulatory submissions.

You will analyze data, support literature reviews, and help improve PMS/PSUR processes, templates, and guidance, contributing as a regulatory documentation expert within a collaborative,

Qualifications

• 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.
• Bachelor's degree in a scientific, technical, engineering, healthcare, or related discipline.
• Strong written and verbal communication skills.

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.

Skills

Quality Assurance

Regulatory Affairs

Pharmacovigilance

Medical Writing

Education

Bachelor's degree

Tools

Microsoft Word

Microsoft Excel

Microsoft Teams

SharePoint

Job description

CooperSurgical is seeking a PSUR Writer II to prepare, maintain, and timely complete PMSPs, PMSRs, and PSURs, ensuring compliance with global regulatory requirements. You will gather data from Clinical, Regulatory, Risk, and Quality teams and summarize safety information for regulatory submissions.

You will analyze data, support literature reviews, and help improve PMS/PSUR processes, templates, and guidance, contributing as a regulatory documentation expert within a collaborative,