Clinical evaluator

Clinical Evaluator An exciting opportunity has arisen for a Clinical Evaluator to join our thriving UK Medical Manufacturing Company. Working as an integral part of the Clinical Evaluation Team, the successful candidate will take responsibility for the creation and maintenance of Clinical Evaluation Plans/Reports (CEP/CER) to ensure compliance to medical device regulations. This includes conformity to the essential requirements of Medical Device Directive 93/42/EEC, and general safety performance requirements as per Medical Device Regulation 2017/745. You will be working as a part of the team and will be required to prioritise, multi-task and work in a fast pacing environment. For the right candidate there is the potential for us to support this as a remote working role from any country which has an Intersurgical Subsidiary. Key Responsibilities (but not limited to): bull; Creation and maintenance of Clinical Evaluation according to MEDDEV 2.7.1, Rev. 4 and compliant to EU/UK MDR (Medical Device Regulation) bull; Identifying, interpreting, evaluating and incorporating information from various sources appropriate to the device bull; Analysing post-market surveillance data and risk management data to ensure consistency and alignment in CER (Comparative Effectiveness Research) bull; Evaluating clinical evidence from published literature, post-market surveillance, risk assessments and post-market clinical data, and be able to generate a report of these data bull; Ensure that Clinical Evaluation Plans/Reports and databases are kept compliant and up to date bull; Managing timelines and communication to ensure deliverables and milestones are met bull; Assisting and supplying documentation for Technical Files bull; Preparing for and participating in audits as needed Essential Experience/Qualifications: bull; To succeed in this role, you will have: Hands-on experience of writing completing CEP/CERs as per the requirements (a minimum of 5 years rsquo; experience) bull; A university degree, or equivalent qualification within a relevant Life Sciences subject, a higher degree or PhD would be advantageous bull; Knowledge and experience with Medical Devices Directive 93/42/EEC, EU/UK MDR, MEDDEV 2.7.1 Rev 4 Clinical Evaluations bull; Significant experience in understanding, reviewing and analysing scientific data and literature bull; Able to produce clear and concise technical documentation to strict deadlines Desirable Experience/Qualifications: bull; Knowledge of ISO14971 Risk Management bull; Previous experience in the medical device industry would be advantageous but not essential Key Skills: bull; Data analysis bull; Good communication bull; Able to work to deadlines bull; Able to multitask and prioritise workload bull; Able to make decisions and self-manage bull; Able to work in a team and on own initiative bull; Self-motivated and willing to learn bull; Can-do attitude with an enthusiastic approach to work bull; I.T. Literate ndash; Microsoft Office/Excel bull; Medical writing bull; Methodical, organised and structured approach to work bull; Excellent attention to detail bull; Excellent report writing skills bull; Able to gather, evaluate, critically interpret and communicate complex information bull; Able to function in a highly regulatory environment with a focus on compliance bull; High level of commitment bull; Excellent English technical writing and grammar skills bull; Problem solving bull; Flexibility to work additional hours if required to support the requirements of the role Hours of Work: bull; 40 hours per week bull; Flexibility to start and finish times **No Agencies Please** Why Join Intersurgical You 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. Location: Head Office (Wokingham UK) Job Type: Full time, 40 hours per week Contract Type: Permanent Salary: GBP40,000-GBP45,000 Benefits: Family feel company bull; Flexible working hours bull; Training and progression opportunities bull; Annual performance and salary review bull; Competitive annual leave entitlement bull; Generous Company contribution toward gym membership bull; Matched pension contributions with length of service bull; Cycle to Work Scheme Closing date: 31-05-2024 You may also have experience in the following: Clinical Assessment Specialist, Medical Device Evaluator, Clinical Evidence Analyst, Regulatory Evaluation Specialist, Comparative Effectiveness Researcher, Clinical Evidence Coordinator, Medical Evaluation Analyst, Clinical Documentation Evaluator, Device Compliance Analyst, etc. REF-(Apply online only)