Clinical Researcher

Location: Head Office (Wokingham UK)
Job Type: Full time, 40 hours per week
Contract Type: Permanent
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: 10-05-2024

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

The successful candidate will assist with 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.

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)
• Ensure that clinical evaluation plans/reports and databases are kept compliant and up to date.
• Assisting and supplying documentation for technical files
• Administration of the team like organising webinars, taking care of credit card purchases and organising team events.

Essential Experience/Qualifications:

• A university degree, or equivalent qualification within a relevant Life Sciences subject, a higher degree or PhD would be advantageous.
• 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:

• Previous experience in the medical device industry or medical writing experience
• Ability to interpret, analyse, and report statistical data from clinical studies to meet regulatory obligations, and for scientific publication or presentation.

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.

You may also have experience in the following: Clinical Scientist, Medical Device Researcher, Clinical Affairs Specialist, Regulatory Research Analyst, Biomedical Researcher, Scientific Data Analyst, Clinical Study Coordinator, Medical Research Associate, Clinical Documentation Specialist, Regulatory Affairs Researcher, etc

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