Senior PSUR Writer

Job not on LinkedIn

🔥 12 hours ago

🦌 Connecticut, New Jersey – Remote

🦌 Connecticut – Remote 🏖️ New Jersey – Remote

💵 $100k - $130k / year

⏰ Full Time

🟠 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

• Lead the authoring, review, and maintenance of PSURs, PMSPs, PMSRs, and related post-market surveillance documentation • Independently manage multiple product families and report cycles simultaneously • Interpret and analyze complaint, vigilance, clinical, literature, CAPA, trend, and risk management data to support safety assessments • Develop comprehensive safety narratives, conclusions, and risk-benefit evaluations • Serve as the primary cross-functional liaison for PSUR development activities • Ensure compliance with EU MDR 2017/745, FDA requirements, ISO 13485, and ISO 14971 expectations • Identify safety signals, emerging trends, and potential regulatory risks • Provide recommendations regarding risk management file updates and surveillance strategies • Lead the development, implementation, and maintenance of global procedures, work instructions, templates, and best practices related to PMSPs, PMSRs, and PSURs • Establish and maintain standardized authoring templates across product portfolios • Identify gaps in PMS processes and drive process improvement initiatives for efficiency, inspection readiness, and regulatory compliance • Provide training and guidance to cross-functional stakeholders on PSUR processes, procedures, and documentation requirements • Partner with Regulatory Affairs, Quality Assurance, Clinical Affairs, and Risk Management on PMS documentation lifecycle management • Mentor and provide technical guidance to junior PSUR writers and other team members • Support regulatory inspections, audits, and responses related to PMS documentation • Present findings and status updates to management and cross-functional stakeholders • Escalate significant compliance risks, resource concerns, and timeline impacts • Perform other duties as assigned

🎯 Requirements

• Advanced knowledge of EU MDR 2017/745, FDA regulations, ISO 13485, ISO 14971, and post-market surveillance requirements • Strong scientific and technical writing abilities • Ability to independently interpret complex safety, clinical, and quality data • Strong project leadership and stakeholder management skills • Excellent analytical, critical-thinking, and problem-solving capabilities • Experience leading cross-functional initiatives • Advanced proficiency in Microsoft Office applications and document management systems • Strong understanding of medical device risk management principles and post-market surveillance processes • Ability to mentor and train junior team members • 5+ years experience in Medical Writing, Regulatory Affairs, Post-Market Surveillance, Pharmacovigilance, Clinical Affairs, or Quality Assurance within the medical device industry • 3+ years experience authoring PSURs, PMSRs, PMS Plans, CERs, or equivalent regulatory documentation • Experience independently leading complex regulatory writing projects • Bachelor's degree required in a scientific, technical, engineering, healthcare, or related discipline • Advanced degree preferred • Ability to work remotely in the US • 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 • Other perks and benefits • Potential eligibility for other types of compensation and benefits