We’re Hiring: Senior Regulatory Affairs Specialist (IVDR – CDx)
📍 Location: UK (Remote or Hybrid – Warrington / Grange)
🕒 Type: Full-time | 12-month contract
📅 Start Date: ASAP
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