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Regulatory Affairs Consultant, IVD

Hertfordshire   •  £60 - £70 per hour  •  Contract/Temporary, Full time


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

Within this role you will be responsible for:

  • Develop and maintain country specific product regulatory processes including device registration, data/record management, post market surveillance and vigilance
  • Compliance with and implementation of Global Quality and Regulatory processes
  • Communication with National
  • Competent Authorities

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
  • Monitoring of Regulatory requirements
  • Review and implementation of new legislation/regulations applicable to UK and Ireland
  • Develop and maintain a comprehensive understanding of the current and future regulatory landscape, attending conferences to keeping up to date with developments in the appropriate laws and guidance
  • To establish and maintain effective communications with the Competent Authorities in UK and Ireland ensuring compliance with the requirements of these competent authorities.
  • 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 Regulatory Affair Manager in the development, planning and execution of project work with the aim of improving the Regulatory Affairs function.

Required Experience:

  • Extensive professional experience in Regulatory Affairs in the medical device or diagnostics industry
  • Expertise in IVDs preferred
  • Thorough knowledge and understanding of medical device quality system requirements (e.g. ISO/MDR/IVDR/UKMDR)
  • Working with Notified Bodies
  • Medical Device Registration
  • Understanding of the current IVD Regulatory
  • Framework and processes, GB and EU
  • Working with confidential information
  • Knowledge and understanding of regulatory affairs, especially European and GB regulations governing product safety, ideally with demonstrable experience as a regulatory specialist in industry or consultancy
  • Submission and maintenance of regulatory documentation
  • Communicating with competent Authorities

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-33185-1
  • Posted: 6th June 2022
  • Expires: 4th July 2022

Achieva Group Limited

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