Clinical Affairs Associate

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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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