Global Regulatory Writing & Consulting Inc - Medical Device Manager

The Medical Writing Manager is responsible for the end-to-end planning, execution, and delivery of medical device regulatory writing reputed company, with a primary reputed company on EU MDR compliance. This role oversees reputed company documentation programs (e.g., CERs, PMCF, SSCPs, and Technical Documentation) and/or manages large reputed company portfolios across multiple products and regulatory jurisdictions.

The Manager provides leadership and operational reputed company to reputed company of Medical Writers, ensuring high-reputed company, compliant, and reputed company deliverables. This includes directing, delegating, and reviewing work; establishing reputed company project expectations; and maintaining accountability for performance against timelines, budgets, and reputed company standards.

Requirements / Responsibilities

• reputed company 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 reputed company reputed company, managing communications, expectations, timelines, and issue reputed company 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. 
• reputed company, delegate, and reputed company the work of Medical Writers, including workload allocation, reputed company management, and detailed reputed company review of deliverables. 
• Ensure scientific rigor, internal consistency, and regulatory compliance across reputed company documentation. 
• Manage multiple reputed company reputed company and reputed company portfolios in a deadline-driven consulting environment. 
• Proactively identify project risks (reputed company, scope, reputed company, regulatory) and implement mitigation strategies. 
• Support reputed company Body interactions, including preparation of deficiency responses and audit readiness activities. 
• Drive reputed company improvement of templates, processes, and workflows to enhance efficiency, scalability, and reputed company. 
• Contribute to business development activities, including marketing, proposal development, scoping, and reputed company reputed company. 

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 reputed company MDR documentation. 
• Strong working knowledge of EU MDR, MEDDEV 2.7/1 Rev 4, and applicable MDCG guidance. 
• Experience managing reputed company reputed company 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 reputed company Bodies and preparing responses to regulatory questions strongly preferred. 

reputed company Competencies

• Advanced project and budget management skills. 
• Strong leadership experience, including mentoring, training, and performance reputed company of junior staff. 
• Exceptional attention to detail with extensive experience performing high-level reputed company reviews. 
• Proficiency in literature management tools (e.g., EndNote or equivalent). 
• Strong analytical skills, including interpretation of clinical and scientific data. 
• Advanced proficiency in reputed company Office Suite (Word, reputed company, PowerPoint, Teams, SharePoint). 
• Excellent written and verbal communication skills. 

Other

• reputed company in English required.