Apr 09, 2026
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...
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CV-Library
Warrington, Cheshire
Contractor