Global Regulatory Writing & Consulting Inc - Medical Device Manager

Global Regulatory Writing & Consulting Inc - Medical Device Manager In order to use this site, it is necessary to enable JavaScript. Here are the instructions how to enable JavaScript in your web browser . All Jobs > Medical Device Manager Global Regulatory Writing & Consulting Inc Apply Medical Device Manager Remote Worker - N/A Apply Description 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 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. Requirements Requirements / Responsibilities Lead end-to-end project management for EU MDR regulatory writing deliverables, including Clinical Evaluation Reports (CERs), PMCF documentation, SSCPs, and Technical Documentation. Serve as the primary client interface, managing communications, expectations, timelines, and issue resolution across ongoing engagements. Interpret and operationalize regulatory requirements (EU MDR, MEDDEV 2.7/1 Rev 4, MDCG guidance) into executable project plans and writing strategies. Direct, delegate, and oversee the work of Medical Writers, including workload allocation, timeline management, and detailed quality review of deliverables. Ensure scientific rigor, internal consistency, and regulatory compliance across all documentation. Manage multiple concurrent projects and client portfolios in a deadline-driven consulting environment. Proactively identify project risks (timeline, scope, quality, regulatory) and implement mitigation strategies. Support Notified Body interactions, including preparation of deficiency responses and audit readiness activities. Drive continuous improvement of templates, processes, and workflows to enhance efficiency, scalability, and quality. Contribute to business development activities, including marketing, proposal development, scoping, and client onboarding. Qualifications 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. Salary Description 125,000 - 150,000 Apply View All Jobs Powered by Payroll & HR Software