RA Registration Officer (Medical Device) Remote

  • Location
    Newcastle Upon Tyne, Tyne And Wear
  • Job type
    Permanent
  • Industry
    Pharmaceuticals
  • External Reference
    JN-032022-243678
  • Category
    Science - Science

Regulatory Affairs Registration Officer (Medical Device) Remote, £28,500


Our 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.

To speak to a recruitment expert please contact Olivia Cann