PSUR Writer II

Job not on LinkedIn

🔥 0 minutes ago

🦌 Connecticut – Remote

🦌 Connecticut – Remote

💵 $75k - $100k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

✏️ Content Writer

👻 Ghost score 7%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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CooperCompanies

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1978

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

💰 Post-IPO Equity on 2021-12

Healthcare • Consulting • Food & Beverage

CooperCompanies is a global, consumer-centric medical device company that supports how people want to live at every stage of life. The company is dedicated to improving lives by listening closely to healthcare providers and patients to fulfill the needs of today while focusing on the opportunities of tomorrow through innovation and strategic investment. Their prominent divisions, CooperVision and CooperSurgical, are committed to addressing issues such as myopia in children and supporting families struggling with infertility. CooperCompanies actively engages in sustainable practices and seeks to elevate standards of care with a strong focus on social and environmental impact.

📋 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