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 preferredWhat 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