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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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