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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: Exciting role with excellent project management and communication opportunities.
- Why this job: Make a real impact in cutting-edge diagnostics while collaborating globally.
- 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 Hemel Hempstead 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 Hemel Hempstead
✨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 skills. Tailor your approach to each opportunity!
✨Tip Number 4
Follow up after interviews! A simple thank-you email can go a long way in keeping you top of mind. We believe it shows your enthusiasm and professionalism, which are traits every employer loves.
We think you need these skills to ace Senior Regulatory Affairs Specialist (IVDR – CDx) in Hemel Hempstead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Affairs Specialist role. Highlight your experience in 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, mention instances where you've successfully worked with different departments or stakeholders.
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 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
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 teamwork 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 chance to assess if the company aligns with your career goals.