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