Medical Writing Manager – EU MDR

Company Description Global Regulatory Writing & Consulting (GLOBAL) specializes in providing expert consulting, regulatory submission support, and strategic writing services for the pharmaceutical and medical device industries. The company focuses on delivering tailored, high-quality solutions to help clients navigate complex regulatory pathways with confidence. GLOBAL offers a wide range of core services, including regulatory strategy, clinical trial and marketing application authoring, lifecycle management, and clinical and non-clinical medical writing. With deep expertise and a dedicated team, GLOBAL combines the resources of a leading contract research organization (CRO) with the personal attention and flexibility of a smaller, agile partner. Role Description This is a full-time remote role for a Medical Writing Manager. The Medical Writing Manager is responsible for the end-to-end planning, execution, and delivery of medical device regulatory writing projects, with a primary focus on EU MDR compliance. This role oversees complex documentation programs (e.g., CERs, PMCF, SSCPs, and Technical Documentation) and/or manages large client portfolios across multiple products and regulatory jurisdictions. The Medical Writing Manager provides leadership and operational oversight to a team of Medical Writers, ensuring high-quality, compliant, and timely deliverables. This includes directing, delegating, and reviewing work; establishing clear project expectations; and maintaining accountability for performance against timelines, budgets, and quality standards. Qualifications • Experience in Medical Writing, including the creation of clinical or non-clinical documents for regulatory submissions. • Knowledge of Regulatory Submissions and Regulatory Affairs processes, especially as they pertain to medical devices. • Strong foundation in Writing and communication skills with attention to detail and clarity. • Understanding of medical terminology and the life sciences field, including familiarity with medicine and clinical research. • Proven leadership and team management skills, with the ability to mentor and develop writers. • Proficiency with regulatory guidelines and standards, such as FDA, EU MDR, and ISO requirements. • Advanced degree (PhD, MD, or equivalent) in life sciences or a related field preferred. • Strong organizational and time management abilities, with a focus on meeting deadlines in a remote work environment. Education • Master’s degree or higher in a scientific, medical, or engineering discipline preferred. Experience • 5+ years of experience in medical device regulatory writing, with demonstrated EU MDR expertise. • Proven experience authoring and leading Clinical Evaluation Reports (CERs) and related MDR documentation. • Strong working knowledge of EU MDR, MEDDEV 2.7/1 Rev 4, and applicable MDCG guidance. • Experience managing complex projects and/or leading teams in a consulting or regulatory environment. • Demonstrated experience conducting comprehensive literature reviews, data appraisal, and state-of-the-art analyses. • Experience interacting with Notified Bodies and preparing responses to regulatory questions strongly preferred. Core Competencies • Advanced project and budget management skills. • Strong leadership experience, including mentoring, training, and performance oversight of junior staff. • Exceptional attention to detail with extensive experience performing high-level quality reviews. • Proficiency in literature management tools (e.g., EndNote or equivalent). • Strong analytical skills, including interpretation of clinical and scientific data. • Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Teams, SharePoint). • Excellent written and verbal communication skills. Other • Fluency in English required.