£80.00 hourly
Manpower UK Ltd
Woolston, Warrington, UK
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...