Medical Device Regulatory Affairs & Clinical Evaluation Manager

Medical Device Regulatory Affairs & Clinical Evaluation Manager Global Regulatory Writing & Consulting (GLOBAL) Bellevue, WA Job Details Full-time 3 hours ago Qualifications FDA submissions Medical writing Project portfolio management Budget management Microsoft Excel Business development within consulting Technical documentation 5 years Engineering Project timeline management English Risk mitigation strategy implementation Improving operational efficiency Master's degree EndNote Client services experience within consulting industry Analysis skills Continuous improvement Team management Staff training Mentoring Data interpretation Microsoft Teams SharePoint Regulatory submissions Budgeting Productivity software Senior level Master's degree in engineering Project leadership Leadership Delegation Communication skills Technical Proficiency Marketing Regulatory compliance management Consulting firm experience Full Job 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 will 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. Job Description 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 will 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.

ABOUT THE COMPANY

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