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 lifecycle
• Collaborate cross-functionally with R&D, Quality, Clinical, and Commercial teams
• Ensure compliance with IVDR (EU 2017/746) and other applicable regulations
• Support 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 devices
• Strong working knowledge of IVDR requirements (essential)
• Experience preparing and managing regulatory submissions and technical documentation
• Ability to work in a fast-paced, cross-functional global environment
• Excellent communication and stakeholder management skills
• Degree in a scientific or related discipline preferred

What you'll get in return
Remote working, good hourly rate, scope for extension
What you need to do now


If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.