Regulatory affairs manager IVD, remote contract job
Your newpany
Our client, a global leader in life sciences and diagnostics, is seeking an experienced Regulatory Affairs Manager to support their expanding IVD portfolio on a contract basis. This is a fantastic opportunity to work at the forefront of diagnostic innovation, ensuring regulatorypliance across key markets.
Your new role
Lead and support regulatory activities for IVD products across global markets (EU, UK, and potentially US/ROW)Prepare, review, and submit regulatory documentation (, IVDR technical files, submissions, change notifications)Provide strategic regulatory guidance throughout the product lifecycleCollaborate cross-functionally with R&D, Quality, Clinical, andmercial teamsEnsurepliance with IVDR (EU 2017/746) and other applicable regulationsSupport audits, inspections, and interactions with notified bodies and regulatory authorities....