Senior Regulatory Affairs Associate

12 hours ago

Edinburgh, Edinburgh, United Kingdom Walker Cole International Full time

Senior Regulatory Affairs Specialist - IVD | Scotland (Hybrid)

Job ID: 87053

A leading In Vitro Diagnostics (IVD) company in Scotland is seeking a Senior Regulatory Affairs Specialist to support and drive regulatory activities across a growing IVD portfolio. This is a hybrid role, offering the opportunity to work on innovative diagnostic products within a collaborative and forward-thinking regulatory team.

This position will suit an experienced Regulatory Affairs professional with strong IVD regulatory experience, ideally across EU IVDR, UKCA, and FDA frameworks, who is looking to take the next step in a senior, hands-on regulatory role.

Your responsibilities as the Senior Regulatory Affairs Specialist will include:

  • Leading and supporting Regulatory Affairs activities for IVD products across the product lifecycle.
  • Preparing, reviewing, and maintaining IVD regulatory submissions, including EU IVDR technical documentation, UKCA files, and FDA submissions where applicable.
  • Acting as a key Regulatory Affairs contact for Notified Bodies, competent authorities, and internal stakeholders.
  • Supporting regulatory strategy development for new and existing In Vitro Diagnostic (IVD) devices.
  • Ensuring ongoing compliance with EU IVDR, IVDD (legacy), UKCA, ISO 13485, and relevant guidance documents.
  • Collaborating cross-functionally with Quality, R&D, Clinical, and Product Development teams.
  • Supporting post-market activities, including change control, vigilance, and lifecycle management.
  • Contributing to continuous improvement of Regulatory Affairs processes and documentation.

To be successful as a Senior Regulatory Affairs Specialist, you will demonstrate:

  • Proven experience working in Regulatory Affairs within an IVD / In Vitro Diagnostics environment.
  • Strong working knowledge of EU IVDR, UKCA requirements, and IVD regulatory frameworks.
  • Experience compiling and maintaining IVD technical files and regulatory submissions.
  • Confidence working with Notified Bodies and regulatory authorities.
  • Excellent communication, organisation, and stakeholder management skills.

This is an excellent opportunity to join a growing IVD company in Scotland, contributing to innovative In Vitro Diagnostic products while developing your career in Regulatory Affairs.

Senior Regulatory Affairs Specialist | Regulatory Affairs | IVD | In Vitro Diagnostics | EU IVDR | UKCA | ISO 13485 | Regulatory Submissions | Technical Documentation | Notified Bodies | Scotland | Hybrid | Medical Devices | Diagnostics | Regulatory Compliance

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