Internal Clinician - London, United Kingdom - DNV
Description
About us:
We are the independent expert in assurance and risk management.
Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.
As a trusted voice for many of the world's most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.
About the role:
DNV Product Assurance AS is one of the leading Notified Bodies for medical devices. The unit is entitled to carry out tasks related to conformity assessment of medical devices with EU Medical Devices Regulation before such products are placed on the market.
The role of
Internal Clinician is to assess clinical data supporting safety and performance of devices.
Main tasks in this role are:
- Approval of Certification Proposals for medical devices to be certified according to the Medical Device Regulation
- Performing assessment and preparing reports of clinical aspects of legal manufacturers technical documentation according to the requirements given in the Medical Device Regulation
- Evaluation of the summary of safety and clinical performance reports for highrisk medical devices
- Review and approval of clinical evaluation report and other relevant clinical documentation for accuracy and compliance with the requirements in the Medical Device Regulation
- Recommend for certification based on reviewed documentation
- Communication with the customers with regards to requirements, status and clinically relevant aspects
- Performing competence review of new resources (clinicians)
- Plan and execute assessment of clinical data as required, within agreed timescales and economic budget
What we offer:
- A competitive compensation and benefit package
- DNV training and qualification program
- A professional community in a prestigious technological company
- Possibilities to work with interesting and challenging projects
- Access to an extensive competence network
About you:
- Medical Doctor
- At least 2 years of working experience including:
- direct work experience in patient care
- Strong written and verbal English communication skills
Personal Qualities:
- Strong technical skills
- Analytical approach
- Good communication skills
- Customer focus
- Excellent reporting skills
- Ability to work independently and efficiently
- Ability to recommend on certification in complex cases
We offer:
- A competitive compensation and benefit package
- DNV training and qualification program
- A professional community in a prestigious technological company
- Possibilities to work with interesting and challenging projects
- Access to an extensive competence network
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