Job Description
Regulatory affairs manager IVD, remote contract jobLead 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 lifecycle Collaborate cross-functionally with R&D, Quality, Clinical, andmercial teams Ensurepliance with IVDR (EU 2017/746) and other applicable regulations Support audits, inspections, and interactions with notified bodies and regulatory authorities....
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