Clinical Affairs Associate

Scotland Source: WhatJobs
£35,000–£50,000

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Clinical Affairs Associate | Diagnostics | Scotland | Hybrid | IVDR-Focused

Are you looking to step out of site monitoring and into a more strategic, cross-functional clinical role?

An established and fast-evolving IVD company based in Scotland is seeking a Clinical Affairs Associate to support clinical performance studies, regulatory documentation, and IVDR compliance for a market-leading diagnostic product portfolio.

This is a unique opportunity for someone with a background in clinical research , such as a CRA or Clinical Study Associate , who’s looking to move into a broader, more collaborative role – working closely with Regulatory Affairs, R&D, and Quality teams.

  • Plan, manage and support clinical performance studies in line with GCP and IVDR requirements
  • Develop clinical protocols, data analysis plans, CRFs and study reports
  • Contribute to scientific validity reports and Instructions for Use (IFUs)
  • Collaborate with external partners and internal teams (Regulatory, QA, R&D)
  • Ensure clinical documentation is audit-ready and aligned with EU regulatory standards
  • Support technical documentation reviews and process improvements
  • Experience supporting or leading clinical study activities (CRA, CTA, Clinical Affairs, etc.)
  • Solid understanding of GCP, ISO 14155 and IVDR or EU regulatory frameworks
  • Excellent written communication and documentation skills
  • Organised, analytical, and comfortable working cross-functionally
  • Looking to move away from field-based roles into strategic office-based work
  • Based in Scotland
  • Hybrid working (2–3 days onsite)

Seniority level

  • Seniority level
  • Mid-Senior level

Employment type

  • Employment type
  • Full-time

Job function

  • Job function
  • Science
  • Industries
  • Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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