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- Tasks: Lead regulatory activities for IVDR CDx performance studies and ensure compliance.
- Company: Join a leading Life Sciences organisation with a dynamic international environment.
- Benefits: Flexible working options, competitive salary, and opportunities for global collaboration.
- Other info: High-impact role with excellent project management and communication skills needed.
- Why this job: Make a real impact in cutting-edge Companion Diagnostics projects.
- Qualifications: Degree in Life Sciences and 3+ years in Regulatory Affairs required.
The predicted salary is between 50000 - 65000 £ per year.
We are looking for a Senior Regulatory Affairs Specialist to join a leading Life Sciences organization within the LSG (Life Sciences Group) EMEA Regulatory Affairs team. This is a fantastic opportunity to work in a dynamic international environment, playing a key role in IVDR CDx performance studies and contributing directly to regulatory strategy, compliance, and market growth across Europe.
- Lead EU Member State notification activities for IVDR CDx performance studies (leftover samples)
- Prepare and submit regulatory documentation to Competent Authorities and Ethics Committees
- Act as the main point of contact with regulatory authorities across the EU
- Collaborate cross-functionally (Clinical, Medical, Legal, Quality, PM)
- Provide regulatory guidance on study design and documentation
- Ensure compliance while supporting business objectives and timelines
What we’re looking for:
- Degree in Life Sciences, Biomedical Sciences, or similar
- 3+ years’ experience in Regulatory Affairs / Clinical Regulatory
- Strong knowledge of IVDR (EU 2017/746) and performance studies
- Experience with EU submissions & interactions with authorities / Ethics Committees
- Excellent project management and communication skills
- Fluent in English
Why join?
- Work on cutting-edge Companion Diagnostics (CDx) projects
- High-impact role supporting RWE and evidence generation strategies
- Flexible working environment (remote/hybrid)
- Opportunity to collaborate across global teams
Senior Regulatory Affairs Specialist (IVDR – CDx) in Kingston upon Hull employer: Oxford Global Resources
Contact Detail:
Oxford Global Resources Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Specialist (IVDR – CDx) in Kingston upon Hull
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of IVDR and performance studies. We recommend practising common interview questions and having examples ready that showcase your experience in regulatory affairs.
✨Tip Number 3
Don’t just apply and wait! Follow up on your applications through our website. A quick email or message can show your enthusiasm and keep you on the radar of hiring managers.
✨Tip Number 4
Showcase your project management skills during interviews. We want to see how you’ve successfully led projects in the past, especially those involving EU submissions and interactions with authorities.
We think you need these skills to ace Senior Regulatory Affairs Specialist (IVDR – CDx) in Kingston upon Hull
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Affairs Specialist role. Highlight your experience with IVDR and any relevant projects you've worked on. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how you can contribute to our team. Be sure to mention specific experiences that relate to the job description.
Showcase Your Communication Skills: Since this role involves collaboration across various teams, it's important to demonstrate your communication skills in your application. Use clear and concise language, and don’t hesitate to share examples of successful teamwork.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Oxford Global Resources
✨Know Your IVDR Inside Out
Make sure you brush up on the IVDR (EU 2017/746) regulations before your interview. Understand the key points and how they relate to performance studies, as this will show your expertise and readiness for the role.
✨Prepare for Regulatory Scenarios
Think about potential regulatory scenarios you might face in the role. Be ready to discuss how you would handle EU Member State notifications or interactions with Competent Authorities. This will demonstrate your problem-solving skills and practical knowledge.
✨Showcase Your Cross-Functional Collaboration Skills
Since the role involves working with various teams like Clinical, Medical, and Legal, prepare examples of how you've successfully collaborated in the past. Highlight your communication skills and how you can bridge gaps between different departments.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the company and the role. Inquire about their current projects in Companion Diagnostics or how they approach compliance challenges. This shows you're engaged and thinking ahead.