Medical Writer – Clinical Compliance

🕒 August 11

🇺🇸 United States – Remote

💵 $124k - $170.5k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥📝 Medical Writer

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Solventum

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

📦 Logistics

💼 Consulting

Healthcare • Logistics • Consulting

Solventum is a healthcare-focused company renowned for its innovative solutions aimed at improving medical and oral care outcomes. The company offers a variety of medical technologies, including advanced wound care, surgical solutions, and sterilization products. Solventum also provides advanced oral care solutions, health information and technology services, and purification and filtration products for biopharmaceutical applications. Furthermore, Solventum places a strong emphasis on sustainability and education, providing resources and training for healthcare professionals globally. Their commitment to innovation and better healthcare has made them a leader in the healthcare industry, dedicated to enhancing patient safety and healthcare efficiencies.

📋 Description

• Author and coordinate Clinical Evaluation Plans and Clinical Evaluation Reports (CEPs/CERs) for new product introductions and sustaining product activities in the Dental Solutions business unit • Collaborate with cross-functional teams to collect, analyze, and assess clinical data in compliance with EU MDR and other global regulatory requirements • Support internal and external audits as a subject matter expert in clinical evaluations • Maintain up-to-date clinical evaluations across the full lifecycle of medical devices • Contribute to Summary of Safety and Clinical Performance (SSCP) reports and regulatory responses with manager/supervisor guidance • Comply with corporate policies, procedures, and security standards while performing assigned duties

🎯 Requirements

• Bachelor’s degree or higher from an accredited institution, preferably in a scientific or technical discipline • Five (5) years of experience in the medical device industry • Minimum of five (5) years of experience in medical writing or technical writing in a regulated industry, preferably aligned to EU MDR requirements • Strong scientific writing and communication skills, with ability to interpret and present clinical data • Dental experience in a private, public, government, or military environment • Demonstrated experience working on cross-functional teams in a global or regulatory environment • Familiarity with SSCP authoring and Class III/implantable medical device regulations in the EU • Excellent attention to detail, time management, and organizational skills • Ability to manage multiple complex projects simultaneously • Strategic thinking, critical thinking, reasoning, and interpretive skills • Proficiency in Microsoft Office applications (Excel, Teams, Word, PowerPoint) with strong analytical skills • Experience utilizing AI technologies to optimize workflows, automate tasks, and enhance operational efficiency • Must be legally authorized to work in the country of employment without sponsorship for employment visa status

🏖️ Benefits

• Variable incentive pay, if eligible • Medical, Dental & Vision benefits • Health Savings Accounts • Health Care & Dependent Care Flexible Spending Accounts • Disability Benefits • Life Insurance • Voluntary Benefits • Paid Absences • Retirement Benefits • Up to 10% domestic travel may be included