Senior Regulatory Affairs Specialist (IVDR – CDx)

We’re Hiring: Senior Regulatory Affairs Specialist (IVDR – CDx)

Location: UK (Remote or Hybrid – Warrington / Grange)

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
• 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

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