Global Regulatory Writing & Consulting Inc - Medical Device Manager

Global Regulatory Writing & Consulting Inc

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 / 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.