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- Tasks: Support clinical studies and regulatory documentation for a leading diagnostic product.
- Company: Join a fast-evolving IVD company making waves in the diagnostics field.
- Benefits: Enjoy hybrid working options and a collaborative team environment.
- Why this job: Transition from site monitoring to a strategic role with impactful contributions.
- Qualifications: Experience in clinical research and knowledge of GCP and IVDR required.
- Other info: Perfect for those seeking a dynamic, office-based career path.
The predicted salary is between 36000 - 60000 £ per year.
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)
Clinical Affairs Associate employer: CPL
Contact Detail:
CPL Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Affairs Associate
✨Tip Number 1
Network with professionals in the clinical research and diagnostics fields. Attend industry conferences or webinars to meet people who work in similar roles, as they can provide insights and potentially refer you to opportunities at their companies.
✨Tip Number 2
Familiarise yourself with the latest developments in IVDR compliance and GCP guidelines. This knowledge will not only boost your confidence during interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 3
Prepare to discuss your experience in clinical study activities and how it relates to the responsibilities of a Clinical Affairs Associate. Think of specific examples where you've collaborated with cross-functional teams, as this is a key aspect of the role.
✨Tip Number 4
Research the company’s diagnostic product portfolio and understand their market position. Being knowledgeable about their products and challenges will help you stand out during interviews and show your genuine interest in the role.
We think you need these skills to ace Clinical Affairs Associate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical research, particularly any roles as a CRA or Clinical Study Associate. Emphasise your understanding of GCP, ISO 14155, and IVDR compliance.
Craft a Compelling Cover Letter: Write a cover letter that showcases your motivation to transition into a strategic role. Mention specific experiences that demonstrate your ability to collaborate with cross-functional teams and your familiarity with regulatory documentation.
Highlight Key Skills: In your application, clearly outline your excellent written communication skills and organisational abilities. Provide examples of how you've successfully managed clinical study activities or contributed to scientific reports.
Proofread Your Application: Before submitting, thoroughly proofread your application for any errors. Ensure that all information is clear, concise, and aligns with the job requirements, especially regarding audit-ready documentation.
How to prepare for a job interview at CPL
✨Understand the Regulatory Landscape
Familiarise yourself with GCP, ISO 14155, and IVDR regulations. Being able to discuss these frameworks confidently will demonstrate your knowledge and readiness for the role.
✨Showcase Your Cross-Functional Experience
Prepare examples of how you've collaborated with different teams in previous roles. Highlighting your ability to work with Regulatory Affairs, R&D, and Quality teams will show that you can thrive in a collaborative environment.
✨Prepare for Technical Questions
Expect questions related to clinical performance studies and documentation processes. Brush up on your understanding of clinical protocols, data analysis plans, and audit-ready documentation to impress your interviewers.
✨Demonstrate Organisational Skills
Be ready to discuss how you manage multiple tasks and projects. Providing specific examples of how you stay organised and analytical in your work will reassure the interviewers of your capability to handle the responsibilities of the role.
