Clinical Evaluator

4 months ago


Wokingham, United Kingdom Intersurgical Full time

Job Advert

An exciting opportunity has arisen for a Clinical Evaluator to join our thriving UK Medical Manufacturing Company.

**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)
- 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



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