The Medical Device Manager is responsible for the end-to-end planning, execution, and delivery of medical device regulatory writing projects across global regulatory frameworks. This role has a primary focus on EU MDR Clinical Evaluation (including CERs), while also supporting premarket regulatory submissions in either the United States (e.g., 510(k), De Novo, PMA) and/or EU MDR Technical Documentation, authoring and strategy. 

The Manager oversees complex documentation programs (e.g., CERs, PMCF, SSCPs, Technical Documentation, and premarket submission dossiers) and/or manages large client portfolios across multiple products and regulatory jurisdictions. 

This role provides leadership and operational oversight to a team of Medtech Medical Writers, ensuring high-quality, compliant, and timely deliverables. Responsibilities include 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 regulatory writing deliverables across EU MDR and/or FDA premarket pathways, including:  
• Clinical Evaluation Reports (CERs)  
• PMCF documentation and plans/reports  
• SSCPs  
• EU MDR Technical Documentation (Annex II/III)  
• FDA premarket submissions (510(k), De Novo, PMA), as applicable  
• Serve as the primary client interface, managing communications, expectations, timelines, and issue resolution across ongoing engagements.  
• Interpret and operationalize regulatory requirements into executable project plans and writing strategies, including:  
• EU MDR, MEDDEV 2.7/1 Rev 4, MDCG guidance  
• FDA device regulations and premarket expectations (as applicable)  
• Lead development of regulatory strategies and submission approaches for both EU and/or US market entry.  
• 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 regulatory authority and Notified Body interactions, including:  
• Preparation of deficiency responses  
• Audit readiness activities  
• Health Authority question responses (FDA and/or EU)  
• 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. 
• Required: Demonstrated experience authoring Clinical Evaluation Reports (CERs).  
• Additionally required (at least one of the following):  
• Experience supporting FDA premarket submissions (510(k), De Novo, and/or PMA), including authoring and/or strategy
  OR  
• Experience authoring and/or leading EU MDR Technical Documentation (Annex II/III) and broader MDR submission strategy  
• Strong working knowledge of:  
• EU MDR, MEDDEV 2.7/1 Rev 4, and applicable MDCG guidance  
• FDA device regulatory framework  
• 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/or FDA 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.