Job Title: Clinical Evaluation Report (CER) Specialist – Medical Devices / IVD Location: Fully Remote (Global) Salary: £40,000 – £45,000 Job Type: Full-time, Permanent About the Role We are a growing Quality Assurance & Regulatory Affairs (QARA) consultancy supporting a diverse portfolio of global medical device and IVD clients. Due to continued expansion, we are looking for a Clinical Evaluation Report (CER) Specialist to join our remote team. This is an excellent opportunity for a science graduate with strong, recent CER writing experience who is confident managing the full lifecycle of clinical evaluations and contributing to regulatory strategy across international markets. Key Responsibilities Author and maintain Clinical Evaluation Reports (CERs) in line with EU MDR and applicable global regulations Lead CER projects end-to-end, from planning and literature review through to final report delivery Perform systematic literature searches, appraisal, and data analysis Ensure compliance with MEDDEV 2.7/1 Rev. 4, MDR, and relevant guidance Collaborate with cross-functional teams including regulatory, clinical, and technical specialists Support broader regulatory activities where required (e.g., technical documentation, PMS, SSCPs) Train and mentor colleagues on CER writing and best practices Contribute to process improvement within the consultancy Requirements Degree in a scientific or clinical discipline (e.g., Life Sciences, Biomedical Science, Pharmacology, or similar) Essential: Recent, hands-on experience writing CERs Demonstrable ability to produce a CER independently from start to finish Strong understanding of clinical evaluation requirements under EU MDR Experience conducting literature reviews and critical appraisal of clinical data Excellent written communication and attention to detail Ability to work independently in a fully remote environment Desirable (Not Essential) Broader regulatory affairs experience (e.g., technical files, risk management, post-market surveillance) Experience with IVDs and/or multiple device classes Previous experience training or mentoring others Familiarity with global regulatory frameworks (FDA, UKCA, etc.) What We Offer Fully remote working with flexible structure Exposure to a wide range of global medical device and IVD projects Supportive, collaborative consultancy environment Opportunity to develop into a senior or lead role, including training responsibilities Competitive salary and long-term career growth