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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 team.
- Benefits: Flexible working options, competitive salary, and opportunities for professional growth.
- Other info: Collaborate globally and enjoy a supportive work environment.
- Why this job: Make a real impact on cutting-edge Companion Diagnostics projects in a high-impact role.
- 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
Locations
Senior Regulatory Affairs Specialist (IVDR – CDx) in Cheshire, Warrington 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 Cheshire, Warrington
✨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 your expertise shine!
✨Tip Number 3
Showcase your project management skills during interviews. We know that being able to juggle multiple tasks is crucial in regulatory affairs, so share examples of how you’ve successfully managed projects in the past.
✨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 proactive about their job search.
We think you need these skills to ace Senior Regulatory Affairs Specialist (IVDR – CDx) in Cheshire, Warrington
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 applications and ensures you get the best chance to join our fantastic 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 Cross-Functional Collaboration
Think about how you've worked with different teams in the past, like Clinical, Medical, or Quality. Be ready to share specific instances where your collaboration led to successful outcomes, as this will demonstrate your ability to work in a dynamic environment.
✨Prepare Questions for Them
Have a few thoughtful questions ready about their regulatory strategy or upcoming projects. This shows your genuine interest in the company and the role, and it gives you a chance to assess if it's the right fit for you too.