Clinical Evaluator
Location: Head Office (Wokingham UK)
Department: Design and Development
Salary: £40,000 - £45,000
Hours: 40
Contract 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 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**
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
REF-(Apply online only)