Senior Regulatory Affairs Specialist
Location: Warrington (Remote/Hybrid)
Rate: £80 per hour
Working Hours: Monday -Friday, flexible between 09:00-18:00
We are seeking a Senior Regulatory Affairs Specialist to join the Life Sciences Group (LSG) EMEA Regulatory Affairs team. In this role, you will lead and support EU Member State notification activities for IVDR CDx performance studies using leftover samples.
You will play a key role in ensuring regulatory compliance while supporting business growth and maintaining competitive advantage across the CDx portfolio.
Key Responsibilities
Lead EU Member State notification activities for IVDR CDx performance studies
Prepare, review, and submit regulatory documentation to Competent Authorities and Ethics Committees
Act as the primary contact for regulatory authorities and respond to queries
Collaborate cross-functionally (Clinical, Medical, Legal, Quality, Project Management)
Maintain accurate regulatory documentation and records
Provide regulatory guidance on study design and submission strategyMinimum Qualifications
Bachelor's degree in Life Sciences, Biomedical Sciences, or related field
3+ years of Regulatory Affairs or Clinical Regulatory experience (IVD, medical device, or pharma)
Experience with EU submissions and Competent Authorities/Ethics Committees
Working knowledge of IVDR (EU 2017/746), especially performance studies
Strong project management and multitasking skills
Excellent written and verbal English communicationSkills & Attributes
Proactive, solution-oriented, and able to work under pressure
Comfortable working independently in a matrix environment
Strong cross-functional collaboration skills
Willingness to travel (10-15%)
Proficient in standard PC/software toolsWork Environment & Benefits
Remote or hybrid working model
International, cross-functional team environment
Laptop and accessories provided
Opportunity to contribute to high-impact regulatory project
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