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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 Stoke-on-Trent 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 Stoke-on-Trent
✨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 creating a list of potential questions and practicing your answers. Confidence is key, so let’s show them what you’ve got!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. We suggest using our website to find roles that excite you and match your expertise in regulatory affairs.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in making a lasting impression. We believe it shows your enthusiasm and professionalism, which can set you apart from other candidates.
We think you need these skills to ace Senior Regulatory Affairs Specialist (IVDR – CDx) in Stoke-on-Trent
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Regulatory Affairs, especially with IVDR and performance studies. We want to see how your background aligns with the role, so don’t be shy about showcasing relevant projects!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about the role and how your skills can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Communication Skills: Since you'll be liaising with various stakeholders, highlight your communication prowess in your application. Whether it's through your CV or cover letter, let us know how you've effectively collaborated in past roles.
Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
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.
✨Prepare for Regulatory Scenarios
Think about potential regulatory scenarios you might face in this position. Prepare examples from your past experience where you successfully navigated similar challenges, as this will demonstrate your problem-solving skills.
✨Showcase Your Cross-Functional Collaboration Skills
Since the role involves working with various teams, be ready to share examples of how you've effectively collaborated with Clinical, Medical, Legal, and Quality teams in the past. Highlighting your communication skills will be key.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s regulatory strategy and how they approach compliance. This not only shows your interest but also gives you a better understanding of their expectations and culture.