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- Tasks: Support clinical studies and regulatory compliance for innovative diagnostic products.
- 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 cross-functional collaboration.
- Qualifications: Experience in clinical research and knowledge of GCP and IVDR regulations required.
- Other info: Perfect for those looking to shift from fieldwork to an office-based position.
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: LinkedIn
Contact Detail:
LinkedIn 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 companies like us.
✨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 cross-functional collaboration. Highlight specific examples where you've worked with regulatory, R&D, or quality teams, as this is a key aspect of the Clinical Affairs Associate role.
✨Tip Number 4
Research our company’s diagnostic product portfolio and recent projects. Being knowledgeable about our work will help you tailor your conversation during interviews and show your genuine interest in joining our team.
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 studies 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 professional, as attention to detail is crucial in clinical affairs.
How to prepare for a job interview at LinkedIn
✨Showcase Your Clinical Research Experience
Make sure to highlight your background in clinical research, especially if you've worked as a CRA or Clinical Study Associate. Be prepared to discuss specific projects you've managed and how they relate to the responsibilities of the Clinical Affairs Associate role.
✨Demonstrate Knowledge of Regulatory Standards
Familiarise yourself with GCP, ISO 14155, and IVDR regulations. During the interview, be ready to explain how you have applied these standards in your previous roles and how you can ensure compliance in this new position.
✨Emphasise Cross-Functional Collaboration
This role requires working closely with various teams such as Regulatory Affairs, R&D, and Quality. Prepare examples of how you've successfully collaborated with different departments in the past and how you can bring that experience to the table.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and ability to handle real-world scenarios. Think about challenges you've faced in clinical studies and how you overcame them, as this will demonstrate your analytical skills and readiness for a strategic role.
