[Hiring] Medical Writer - Clinical Compliance @SOLVENTUM

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description As a Medical Writer – Clinical Compliance, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: • Authoring and coordinating Clinical Evaluation Plans and Clinical Evaluation Reports (CEPs/CERs), to support new product introductions and sustaining product activities in the Dental Solutions business unit. • Collaborating with cross-functional teams to collect, analyze, and assess clinical data in compliance with EU MDR and other global regulatory requirements. • Supporting internal and external audits as a subject matter expert in clinical evaluations. • Maintaining up-to-date clinical evaluations across the full lifecycle of medical devices. • Contributing to Summary of Safety and Clinical Performance (SSCP) reports and regulatory responses with guidance from manager/supervisor. Qualifications • Bachelor’s degree or higher from an accredited institution, preferably in a scientific or technical discipline (Biology, Chemistry, Biomedical Eng, etc.) AND 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 • Knowledge of relevant regulatory guidelines, including EU MDR, FDA, NMPA, and associated clinical evaluation processes • Strong scientific writing and communication skills, with the ability to interpret and present clinical data Requirements • 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 Benefits • Competitive pay and benefits • Medical, Dental & Vision coverage • Health Savings Accounts • Health Care & Dependent Care Flexible Spending Accounts • Disability Benefits • Life Insurance • Voluntary Benefits • Paid Absences • Retirement Benefits Work Location Remote – United States Travel May include up to 10% domestic Relocation Assistance Not authorized Apply tot his job