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Job description
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 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.
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
- Excellentmunication 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
