Clinical Evaluation Specialist - Medical Devices

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

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.