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RA Registration Officer Medical Device Remote

Adecco
Job LocationNewcastle Upon Tyne
EducationNot Mentioned
Salary28,500 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Regulatory Affairs Registration Officer (Medical Device) Remote, £28,500Our client, a rapidly growing Medical Device organisation are looking for a RA Registration Officer to join their team either in Newcastle or on a totally remote basis.Role responsibilities:Assist in meeting regulatory requirements including undertaking registration of medical devices with worldwide regulatory bodies. Review complaints in a timely manner against the established medical device regulatory reporting requirements (e.g. vigilance),as applicable to the product in question, to determine whether those reporting requirements have been met.Regulatory Reporting:

  • Advise on country requirements with regards to changes in regulatory reporting requirements for medical devices and ensure that the Rocket Medical processes are kept up to date.
  • Assist in Rocket Medical meeting regulatory reporting obligations - when applicable - by liaising with relevant bodies and working with colleagues to progress the investigation and to keep all informed and updated as required.
  • Ensure SOPs for these areas are correct at all times.
Registrations:
  • Working knowledge of 93/42/EEC and 510(k) process.
  • Collate technical information for use in regulatory registrations.
  • Prepare and submit regulatory registration applications
  • Ensure all registration information is logged into Q Pulse system.
  • Liaise with the Quality department on aspects of quality related documentation where required.
  • Work alongside NPD and Regulatory team to create technical documentation in support of
  • registrations, if required.
  • Any other tasks that are deemed necessary to fulfil the job role to the satisfaction of the company
  • Ensure naming conventions are consistent throughout all documentation.
Role requirements:
  • Hold a degree or equivalent vocational experience in a life science
  • Has an understanding of Regulatory Bodies product and company registration routes/requirements
  • Working knowledge of 13485, 93/42/EEC & 510(k)
Adecco Lifesciences is acting as an Employment Agency in relation to this vacancy.

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