Global Regulatory Writing & Consulting (GLOBAL)

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 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.