Remote Senior Regulatory Lead, UK IVDR & MHRA Strategy in Amersham

Remote Senior Regulatory Lead, UK IVDR & MHRA Strategy in Amersham

Amersham Full-Time 60000 - 80000 £ / year (est.) No working from home possible
Cepheid

At a Glance

  • Tasks: Lead UK regulatory strategy and ensure compliance for medical devices.
  • Company: Join Cepheid, a part of Danaher, known for innovation in healthcare.
  • Benefits: Remote work, competitive salary, and opportunities for professional growth.
  • Other info: Mentor associates and stay ahead of evolving regulatory changes.
  • Why this job: Make a real impact on healthcare by ensuring device compliance and safety.
  • Qualifications: Experience in regulatory affairs and strong collaboration skills required.

The predicted salary is between 60000 - 80000 £ per year.

Cepheid, part of Danaher, seeks a Principal Regulatory Affairs Specialist (UK, IVDR) to drive UK regulatory strategy, post‑market compliance and lead IVDR/UKCA submissions.

This UK‑based remote role collaborates with the MHRA and cross‑functional teams to ensure devices meet evolving regulatory requirements.

You will mentor associates, coordinate with notified bodies, and monitor EU/UK regulatory changes, applying QMS and risk management across the product lifecycle.

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Remote Senior Regulatory Lead, UK IVDR & MHRA Strategy in Amersham employer: Cepheid

At Cepheid, part of Danaher, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to excel in their roles. As a Remote Senior Regulatory Lead, you will benefit from flexible working arrangements, comprehensive professional development opportunities, and the chance to make a significant impact in the healthcare sector while working alongside dedicated professionals committed to regulatory excellence.

Cepheid

Contact Details:

Cepheid Recruitment Team

We think you need these skills to ace Remote Senior Regulatory Lead, UK IVDR & MHRA Strategy in Amersham

Regulatory Strategy Development
Post-Market Compliance
IVDR/UKCA Submissions
Collaboration with MHRA
Cross-Functional Team Coordination
Regulatory Requirements Monitoring
Quality Management Systems (QMS)