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Regulatory Affairs Consultant, IVD

Hertfordshire   •  £50 - £90 per hour  •  Contract/Temporary, Full time


My client, a Top 10 pharmaceutical company, are currently searching for a Regulatory Affairs Consultant with specialist IVD knowledge to join their team based in Hertfordshire on an initial 12 month contract basis - homebased! 

Within this role you will be responsible for:

  • Ensuring that all products are in regulatory compliance with country specific legislation
  • Ensuring that all post market surveillance processes are fit for purpose and adhered to
  • Country specific product regulatory processes including device registration, data/record management, post market surveillance
  • Compliance with and implementation of Global Quality and Regulatory processes
  • Training of Regional Customer Support Centre Teams on case quality, potentially reportable incident reporting and Aurora Salesforce system
  • Communication with National Competent Authorities
  • To support the Local Safety Officer (LSO) in ensuring that all local business areas comply with guidelines laid out in the local procedures for management of Product Safety Issues and the Global SOPs for Complaint Management .
  • To establish and maintain effective communications with the Competent Authorities in UK and Ireland ensuring compliance with the requirements of these competent authorities.
  • To maintain effective communications with Distributor Country Safety Representatives.
  • To ensure all products are registered with the competent authorities as defined by the IVD Regulations.
  • To work with EEA/Global colleagues to ensure compliance with Quality Management Systems and processes.
  • To keep up to date with current Legislation and ensure compliance.
  • To assist the Local Safety Officer (LSO) in the development, planning and execution of project work with the aim of improving the Safety Office function as directed by the LSO.

Experience:

  • Regulatory Affairs experience in Medical Device Industry
  • Working with Notified Bodies
  • Post market experience
  • Medical Device Registration
  • Understanding of the current IVD Regulatory Framework and processes, UK and EU
  • Technical Product knowledge
  • Training Experience - IT systems and product
  • Working with confidential information
  • Communication with Competent Authorities

Skills:

  • Systems Knowledge
  • Salesforce REXIS Aurora
  • Regulatory Information Management System (RIMS)
  • Effective Team Player
  • Sound business acumen
  • Effective internal and external stakeholder engagement skills
  • Proficient in Microsoft Office and Google tools

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk

  • Agency: Achieva Group Limited
  • Reference: BH-33185
  • Posted: 17th June 2022
  • Expires: 15th July 2022

Achieva Group Limited

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