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- Tasks: Lead regulatory activities for innovative IVDR CDx performance studies across Europe.
- Company: Join a leading Life Sciences organisation with a dynamic international team.
- Benefits: Flexible working options, competitive salary, and opportunities for professional growth.
- Other info: Collaborate globally and support high-impact evidence generation strategies.
- 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.
What you'll be doing:
- 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 Milton Keynes 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 Milton Keynes
✨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 when it comes to landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of IVDR and performance studies. We recommend creating a list of potential questions and practicing your answers. This will help you feel confident and ready to impress!
✨Tip Number 3
Showcase your project management skills! During interviews, share specific examples of how you've successfully managed regulatory submissions or collaborated with cross-functional teams. We want to see how you can contribute to our dynamic environment.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are genuinely interested in joining our team.
We think you need these skills to ace Senior Regulatory Affairs Specialist (IVDR – CDx) in Milton Keynes
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 in your past roles.
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 dynamic team!
How to prepare for a job interview at Oxford Global Resources
✨Know Your IVDR Inside Out
Make sure you brush up on the specifics of the IVDR (EU 2017/746) and performance studies. Being able to discuss recent changes or case studies will show your expertise and enthusiasm for the role.
✨Showcase Your Project Management Skills
Prepare examples from your past experiences where you successfully managed regulatory projects. Highlight how you navigated challenges and ensured compliance while meeting deadlines, as this is crucial for the role.
✨Understand the Company’s Regulatory Landscape
Research the company’s previous submissions and interactions with regulatory authorities. This knowledge will help you tailor your answers and demonstrate that you’re proactive about understanding their specific needs.
✨Practice Cross-Functional Collaboration
Think of instances where you collaborated with different teams like Clinical, Medical, or Quality. Be ready to discuss how you facilitated communication and ensured everyone was aligned towards common goals.