Senior Regulatory Affairs Specialist / Shifts: Mon to Fri 09:00-18:00 Hybrid /Remote/ Full-Time Hourly Rate: £80.00 per hour / 12-month contract.

We’re working with a leading Life Sciences organisation to recruit a Senior Regulatory Affairs Specialist to support IVDR CDx performance study submissions across EU Member States. This role involves managing notification packages, liaising with Competent Authorities and Ethics Committees, and working closely with Clinical, Legal, Quality and Medical teams to ensure compliant and timely submissions.
Key Responsibilities:

• Lead EU Member State notifications for IVDR CDx performance studies.
• Prepare and submit documentation packages.
• Act as the main regulatory contact for authorities.
• Provide regulatory input to cross‑functional project teams.

Requirements:

• Life Science degree or equivalent.
• 3+ years’ experience in Regulatory Affairs within IVD/medical devices/pharma.
• Knowledge of IVDR and EU submission processes.
• Strong communication and project management skills.

Interested?
Apply now to join a global team driving impactful diagnostic innovation.