2 senior regulatory affairs specialist jobs found

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...

Senior Regulatory Affairs Specialist Location: Warrington (Remote/Hybrid) Rate: £50-£60 per hour Working Hours: Mon-Fri, flexible between 09:00-18:00 We are looking for an experienced Senior Regulatory Affairs Specialist to join the Life Sciences Group (LSG) EMEA Regulatory Affairs team. This role will focus on managing and leading IVD and Medical Device registrations across EMEA, ensuring compliance while supporting business growth and market expansion. You will work in a highly collaborative, international environment, partnering across functions to deliver effective regulatory strategies and maintain competitive advantage. Key Responsibilities Lead and manage national product and establishment registrations across EMEA Develop and execute regional regulatory strategies aligned with global objectives Act as key contact for regulatory authorities and distributors Oversee submission activities, track progress, and ensure timely approvals Maintain regulatory databases and...