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Technical Documentation Assessor - UK

  • Job type: Permanent
  • Location: London
  • Salary: Competitive
  • Job reference: 311843/001_1552485057
  • Sector: EPM Scientific, Regulatory
  • Date posted: 13/03/2019

Technical Documentation Assessor

Job type: Permanent

Location: Home Based w/ 20% travel

A leading global Medical Device Notified Body is currently seeking to hire a Technical Documentation Assessor to join their growing team in North America. This role has accountability to ensure the Notified Body Medical Technical Documentation (TD) is performed as per the requirements set out in EU Medical Device Directives and Regulations (e.g. 93/42/EEC).

Key responsibilities of the Technical Documentation Assessor include:

  • Responsible for performing assessments and reviews of client's compliance to the appropriate Quality System and Regulatory requirements in a timely and accurate manner, in accordance with the documented procedures and forms used by the Notified Body

  • Responsible for the timely closure and accuracy of the TD reviews allocated by Technical Documentation Coordinators

  • Responsible for achieving KPI objectives for the TD processes including utilisation, turnaround time and customer satisfaction

  • Deliver customer promise

    • Deliver within agreed turnaround times for customers

    • Deliver and maintain focus on NPS

  • Comply with Quality Management System

Key requirements of the Technical Documentation Assessor include:

  • The role holder should possess a successful completion of a university or a technical college degree or equivalent qualification in relevant studies e.g. medicine, pharmacy, engineering or other relevant sciences

  • 4+ years' experience in in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed

  • Sound knowledge of device legislation, including the general safety and performance requirements set out in Annex I of the MDR

  • Appropriate knowledge of the devices which they are assessing

  • Appropriate knowledge and experience of risk management and related device standards and guidance documents

  • Appropriate knowledge and experience of clinical evaluation

  • Self-motivated and follow timelines set at all times

  • Operates ethically with the highest degree of professional integrity

If you are interested in the Technical Documentation Assessor position working for a Notified Body, apply online today or contact Jamie Remp at +44 203 758 8975 for more information

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