Clinical Evaluator

Intersurgical; England; On-site; GBP 40,000 - 45,000; Full time

Job summary

A medical device manufacturing company based in the UK is hiring a Clinical Evaluator to create and maintain Clinical Evaluation Plans and Reports for regulatory approval. The successful candidate will work in a collaborative environment within the Design and Development Department, engaging in critical evaluations of clinical evidence and ensuring compliance with standards. Ideal for someone with experience in medical device regulations who enjoys a proactive and inclusive workplace. Competitive salary of £40,000 - £45,000 offered.

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 is advantageous.

Responsibilities

• Creation and maintenance of Clinical Evaluation Plans and Reports.
• Identify, interpret, evaluate, and incorporate information for the device.
• Analyse post-market surveillance and risk-management data.
• Evaluate clinical evidence from various sources.
• Ensure Clinical Evaluation Plans/Reports are compliant and up-to-date.
• Assist with documentation for Technical Files.

Skills

Data analysis

Good communication

Able to work to deadlines

Multitasking

Decision-making

Teamwork

IT Literacy

Medical writing

Attention to detail

Excellent report writing skills

Problem solving

Flexibility to work additional hours

Education

Experience in writing Clinical Evaluation Plans and Reports

Knowledge of ISO 14971 Risk Management process

Experience in respiratory medical device industry

Tools

Microsoft Office/Excel

Job description

Location

Head Office (Wokingham UK)

Department

Design and Development

Salary

£40,000 - £45,000

Hours

40 hours per week

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

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-225 673

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