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 strategy
Minimum 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 communication
Skills & 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 tools
Work Environment & Benefits
* Remote or hybrid working model
* International, cross-functional team environmentLaptop and accessories provided
* Opportunity to contribute to high-impact regulatory project
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