Location: Wokingham, Berkshire, South East, UKClinical Evaluator Location: Head Office (Wokingham UK)Department: Design and DevelopmentSalary: £40,000 - £45,000Hours: 40Contract Type: Permanent 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 MDRIdentify, interpret, evaluate, and incorporate information from various sources appropriate to the deviceAnalyse post-market surveillance and risk-management data to ensure alignment in Clinical Evaluation ReportsEvaluate clinical evidence from published literature, post-market surveillance, risk assessments, and post-market clinical dataEnsure that Clinical Evaluation Plans/Reports and databases are kept compliant and up to dateManage timelines and communication to ensure deliverables and milestones are metAssist with and supply documentation for Technical FilesPrepare for and participate in audits as neededAny other duties required by the company Experience/QualificationsExperience in writing and maintaining Clinical Evaluation Plans and ReportsKnowledge of ISO 14971 Risk Management processPrevious experience in the respiratory medical device industry would be advantageous but not essential Key Skills Data analysisGood communicationAble to work to deadlinesAble to multitask and prioritise workloadAble to make decisions and self-manageAble to work in a team and on own initiativeCan-do attitude with an enthusiastic approach to workI.T. Literate
Microsoft Office/ExcelMedical writingMethodical, organised and structured approach to workExcellent attention to detailExcellent report writing skillsAble to gather, evaluate, critically interpret and communicate complex informationAble to function in a highly regulatory environment with a focus on complianceHigh level of commitmentExcellent English technical writing and grammar skillsProblem solvingFlexibility to work additional hours if required Hours of Work 40 hours per weekMonday and FridayFlexible 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** Why Join IntersurgicalYou will be joining a company where our people work together to meet our company goals. We have a strong family feel, a friendly working environment and extend a warm welcome to all new employees. We are looking for commitment, a strong work ethic and flexibility in all our people and reward those that demonstrate these qualities. Intersurgical is only as good as the people who work for us and we value all of our employees REF-225 673TPBN1_UKTJ