Regulatory Affairs Manager IVD

Regulatory affairs manager IVD, remote contract jobYour new company 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 regulatory compliance 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 (e.g., IVDR technical files, submissions, change notifications)Provide strategic regulatory guidance throughout the product lifecycleCollaborate cross-functionally with RandD, Quality, Clinical, and Commercial teamsEnsure compliance with IVDR (EU 2017/746) and other applicable regulationsSupport audits, inspections, and interactions with notified bodies and regulatory authorities.What you''ll need to succeed Proven experience in Regulatory Affairs within IVD or medical devicesStrong working knowledge of IVDR requirements (essential)Experience preparing and managing regulatory submissions and technical documentationAbility to work in a fast-paced, cross-functional global environmentExcellent communication and stakeholder management skillsDegree in a scientific or related discipline preferredWhat you''ll get in return Remote working, good hourly rate, scope for extensionWhat you need to do nowIf you''re interested in this role, ..... full job details .....