Senior Clinical Affairs Specialist

Senior Clinical Affairs Specialist (Remote)Our medical device client are currently recruiting for a Senior Clinical Affairs Specialist to join their team on a permanent basis. As Senior Clinical Affairs Specialist you will be responsible for developing and executing global clinical strategies to support regulatory submissions, product approvals, and post-market evidence requirements. As Senior Clinical Affairs Specialist you will ensure clinical data integrity, oversee clinical evaluations, and contribute clinical insights throughout the product lifecycle. Experience with MDR and working with class III medical devices is an essential requirement. This role provides remote working while also providing the opportunity with work on site if you so wish. ResponsibilitiesDevelop clinical strategies and evidence plans for regulatory submissions and post-market requirementsLead or contribute to clinical evaluations, literature reviews, data appraisal and analysis, and generation of clinical evidence reportsServe as the clinical representative on product development teams and collaborate cross-functionally with regulatory, quality, and R&D groupsPrepare interim and final clinical reports, oversee investigator training, and support clinical trial monitoringProvide clinical assessment for complaints, recalls, and other safety-related decisionsEngage with regulatory authorities to support approvals and respond to queriesSupport clinical training initiatives and the development of advisory boardsMaintain compliance with relevant clinical, regulatory, quality, and safety standardsManage clinical deliverables within defined timelines and budgetsRequirementsDegree in a scientific, engineering, health science or related field (or extensive relevant experience)Recognised subject matter expertise with a minimum of five years of experience in the medical device industryExperience with high-risk or implantable devices and global regulatory submissionsProficiency in clinical evaluation methodologies, systematic literature reviews, and medical writingStrong knowledge of medical device regulations (e.g., MDR 2017/745, FDA requirements) and associated guidanceExperience in clinical trial activities across feasibility, pivotal, and post-market stagesAbility to work independently and collaboratively within multidisciplinary teamsExperience interacting with clinicians and other healthcare professionals