Clinical Evaluator

Description:

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):

• Creation and maintenance of Clinical Evaluation according to MEDDEV 2.7.1, Rev. 4 and compliant to EU/UK MDR (Medical Device Regulation)
• Identifying, interpreting, evaluating and incorporating information from various sources appropriate to the device
• Analysing post-market surveillance data and risk management data to ensure consistency and alignment in CER (Comparative Effectiveness Research)
• 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
• Ensure that Clinical Evaluation Plans/Reports and databases are kept compliant and up to date
• Managing timelines and communication to ensure deliverables and milestones are met
• Assisting and supplying documentation for Technical Files
• Preparing for and participating in audits as needed

Essential Experience/Qualifications:

• 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’ experience)
• A university degree, or equivalent qualification within a relevant Life Sciences subject, a higher degree or PhD would be advantageous
• Knowledge and experience with Medical Devices Directive 93/42/EEC, EU/UK MDR, MEDDEV 2.7.1 Rev 4 Clinical Evaluations
• Significant experience in understanding, reviewing and analysing scientific data and literature
• Able to produce clear and concise technical documentation to strict deadlines

Desirable Experience/Qualifications:

• Knowledge of ISO14971 Risk Management
• Previous experience in the 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
• Self-motivated and willing to learn
• 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 to support the requirements of the role

Hours of Work:

• 40 hours per week
• 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: £40,000-£45,000
Benefits: Family feel company • Flexible working hours • Training and progression opportunities • Annual performance and salary review • Competitive annual leave entitlement • Generous Company contribution toward gym membership • Matched pension contributions with length of service • 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)