Remote Senior Quality Regulatory Specialist

  • Location
    London, Greater London
  • Salary
    £ 60000 - £ 80000 / Year
  • Job type
  • Industry
  • External Reference
  • Category
    Science - Quality Assurance

*Remote Senior QARA Role, IVD Sector*

Adecco are working with a successful consultancy business looking for a Senior Consultant to join the team on a permanent basis.

Due to the high demand for their services, the business are seeking a highly experienced Quality Assurance and Regulatory Affairs professional to work within their In-Vitro Diagnostics team.

Joining the company in a senior role, you will be responsible for supporting a variety of client projects such as IVD to IVDR transition, device global market entry, submission review, QMS gap assessments and writing standard processes for compliance.

Responsibilities include:

  • Providing clear guidance and consultation on quality and regulatory standards as applicable to their clients, writing and implementing processes.

  • Writing documentation which includes regulatory submissions and technical files compliant with IVDR.

  • Complete internal audits on behalf of clients to ISO 13485:2016

To be considered for this position the company are looking for:

  • At least 5 years' experience working with IVDs

  • Experience of global registrations, UK and Europe is essential

  • Experienced Lead Auditor

This position is remote, with occasional travel when required.

If you could be interested in learning more, please apply and we can discuss further.

Adecco Lifesciences is acting as an Employment Agency in relation to this vacancy.

To speak to a recruitment expert please contact Amy Holder