Clinical Evaluation Writer – Hybrid (9-Month Contract | High Chance of Extension | Occasional Travel to Ireland)Position SummaryThe Clinical Evaluation Writer is responsible for providing clinical and medical writing support for assigned medical device projects to ensure compliance with EU Medical Device Directive (MDD) and Medical Device Regulation (MDR). This role plays a critical part in preparing high-quality clinical documentation for new and existing products and indications.This is a 9-month contract position with a high likelihood of extension, operating in a hybrid working model with occasional travel to Ireland. The position primarily focuses on the development of Clinical Evaluation Plans (CEPs)and Clinical Evaluation Reports (CERs), as well as supporting regulatory submissions to Notified Bodies and other regulatory authorities. The role may also support clinical investigation planning and post-market clinical follow-up activities to ensure ongoing MDR conformity.Key ResponsibilitiesClinical & Regulatory WritingPrepare, write, edit, and review:Clinical Evaluation Plans (CEPs)Clinical Evaluation Reports (CERs)Post-Market Clinical Follow-up Plans (PMCFPs)Post-Market Clinical Follow-up Reports (PMCFRs)Instructions for Use (IFUs)Summary of Safety and Clinical Performance (SSCPs)Ensure all documents comply with:EU MDR 2017/745MEDDEV 2.7.1 Rev. 4Relevant MDCG guidance documentsApplicable ISO standardsClinical Data & Literature EvaluationDesign, conduct, and document systematic literature searches in biomedical databases (e.g., PubMed, Cochrane Library)Critically appraise, grade, analyze, and summarize clinical dataEstablish clinical evaluation acceptance criteriaPerform quantitative comparisons of subject device data to relevant state-of-the-art evidence to demonstrate compliance with General Safety and Performance Requirements (GSPRs)Prepare clinical figures, tables, reports, and scientific presentationsRisk Management & Clinical Research SupportProvide clinical input into medical device risk management processes in accordance with ISO 14971Support clinical investigations in compliance with ISO GCP for medical devices) by preparing and reviewing:Clinical Investigation Plans (CIPs)Investigator Brochures (IBs)Case Report Forms (CRFs)Regulatory & Compliance ExpertiseMaintain a strong understanding of current and evolving global medical device regulationsInterpret regulatory guidance and communicate regulatory impacts internally and with clientsSupport submissions to Notified Bodies and other regulatory agenciesInformation & Evidence ManagementEstablish and oversee digital clinical evidence librariesEnsure clinical documentation and supporting evidence are accurately organized, traceable, and maintainedClient & Project ManagementSupport client engagement through:Project scoping and proposal writingProposal management and schedulingLeading weekly client progress callsCollaborate cross-functionally with project teams to ensure timely and high-quality deliverablesQualifications & EducationBachelor's degree (or equivalent) in a medical, life science, or healthcare-related discipline requiredPostgraduate degree preferredMinimum of 5 years of professional experience in a life science, healthcare, or medical writing roleDemonstrated expertise in clinical/scientific writing and medical device documentationRequired Skills & CompetenciesAdvanced medical writing skills with strong experience in:Systematic literature reviewsClinical data appraisalRegulatory clinical documentationExcellent attention to detail and ability to critically evaluate scientific informationFluency in written and spoken EnglishStrong verbal and written communication skillsHigh proficiency in:Microsoft Word, Excel, SharePoint, Teams, and OutlookExperience with document control within a Quality Management System (QMS) is strongly preferredExcellent interpersonal, organizational, and client service skillsPreferred Knowledge & ExperienceClinical research methodology, including:Clinical investigation designBiostatisticsInformation management and data retrieval systemsExperience using medical literature databases (e.g., PubMed, Cochrane Library)Strong knowledge of EU medical device regulatory requirements