2 senior regulatory affairs specialist jobs found in Warrington

Senior Regulatory Affairs Specialist (EMEA) Location: Warrington (Remote or Hybrid options available) Duration: 12-Month Contract Pay Rate: £50.00 - £60.00 per hour Work Pattern: Monday - Friday, 37.5 hours per week (Flexible hours between 09:00 and 18:00) The Role We are seeking a high-energy Senior Regulatory Affairs Specialist to provide leadership and strategic support for IVD/MD (In Vitro Diagnostic and Medical Device) registrations across the EMEA region. Reporting to the Director of Regulatory Affairs EMEA, you will work within a dynamic, international environment to ensure market growth and revenue protection through strict regulatory compliance. This is a versatile role that can be performed remotely or as a hybrid arrangement out of our Warrington site, with occasional business travel (approx. 10-15%) for escalations and site visits. Key Responsibilities Registration Leadership: Lead national product and establishment registrations across EMEA markets, ensuring all...

Sr. Regulatory Affairs Specialist Are you a proactive regulatory professional looking to lead critical compliance activities in the life sciences sector? We are seeking a Sr. Regulatory Affairs Specialist to join a dynamic international team for a 12-month contract. This role offers the flexibility of remote or hybrid working and is based out of Warrington. The Role In this leadership-focused position, you will provide hands-on support for EU Member State notifications concerning IVDR CDx performance studies. You will be responsible for developing regulatory application strategies that align with business objectives, ensuring timely submissions and maintaining full regulatory compliance across the EMEA region. Your Responsibilities Notification Management: Lead and manage notification activities for IVDR CDx performance studies involving leftover samples. Documentation & Submission: Prepare, review, and submit notification packages to EU Competent Authorities and Ethics...