Job Description

Job Advert


We are looking to recruit a Clinical Evaluator who will be responsible for creating and maintaining Clinical Evaluation Plans and Reports in compliance with relevant standards and regulations for medical device regulatory approval.



The successful candidate will join our thriving UK medical device manufacturing company and work within our Design & Development Department.

Key Responsibilities Include (but not limited to)

Creation and maintenance of Clinical Evaluation Plans and Reports, including new development projects according to MEDDEV 2.7.1, Rev. 4 and compliant to EU/UK MDR Identify, interpret, evaluate, and incorporate information from various sources appropriate to the device Analyse post-market surveillance and risk-management data to ensure alignment in Clinical Evaluation Reports Evaluate clinical evidence from published literature, post-market surveillance, risk assessments, and post-market clinical data Ensure that Clinical Evaluation Plans/Reports and databases are kept compliant and up to date Manage timelines and communication to ensure deliverables and milestones are met Assist with and supply documentation for Technical Files Prepare for and participate in audits as needed Any other duties required by the company

Experience/Qualifications

Experience in writing and maintaining Clinical Evaluation Plans and Reports Knowledge of ISO 14971 Risk Management process Previous experience in the respiratory medical device industry would be advantageous but not essential

Key Skills

Data analysis Good communication Able to work to deadlines Able to multitask and prioritise workload Able to make decisions and self-manage Able to work in a team and on own initiative Can-do attitude with an enthusiastic approach to work I.T. Literate - Microsoft Office/Excel Medical writing Methodical, organised and structured approach to work Excellent attention to detail Excellent report writing skills Able to gather, evaluate, critically interpret and communicate complex information Able to function in a highly regulatory environment with a focus on compliance High level of commitment Excellent English technical writing and grammar skills Problem solving Flexibility to work additional hours if required

Hours of Work

40 hours per week Monday and Friday Flexible to start and finish times

Equal Opportunities

We are committed to creating a diverse and inclusive workplace for all. We are an Equal Opportunities Employer and welcome applications from all individuals, regardless of age; disability; gender; gender reassignment; marital or civil partnership status; pregnancy and maternity; race; religion or belief; sexual orientation, or any other characteristic protected by law. We believe that diversity enriches our workplace and enhances our ability to deliver exceptional results. We assess all applications based on skills, qualifications, and experience, ensuring a fair and equitable recruitment process.

No Agencies please