Clinical Affairs Associate

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. Key Responsibilities: 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 ✅ Ideal Profile: 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 Location & Working Model: Based in Scotland Hybrid working (2–3 days onsite)

Location: Scotland,, GB

Posted Date: 7/14/2025