Senior Regulatory Affairs – EU IVDR Perf. Studies (Remote)

Senior Regulatory Affairs – EU IVDR Perf. Studies (Remote)

Temporary 63000 - 77000 Β£ / year (est.) Home office (partial)
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At a Glance

  • Tasks: Plan and coordinate regulatory submissions for innovative diagnostics.
  • Company: Global Diagnostics Manufacturer with a focus on cutting-edge technology.
  • Benefits: Remote work flexibility, competitive pay, and professional growth opportunities.
  • Other info: 12-month contract with occasional on-site presence in the north of England.
  • Why this job: Join a dynamic team and make a difference in healthcare innovation.
  • Qualifications: Experience in regulatory affairs and strong collaboration skills.

The predicted salary is between 63000 - 77000 Β£ per year.

EPM Scientific, in partnership with a Global Diagnostics Manufacturer, seeks a Sr.

Regulatory Affairs Specialist to support EU Competent Authorities and MHRA with performance study applications for CDx programs.

This contract role is 12 months, predominantly remote with occasional on-site presence in the north of England.

You will plan and coordinate regulatory submissions, maintain IVDR documentation, and align strategy with cross-functional teams (Clinical, QA, R&D, and Regulatory).

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Senior Regulatory Affairs – EU IVDR Perf. Studies (Remote) employer: EPM Scientific

As a Senior Quality Engineer in Belfast, you will join a dynamic team dedicated to excellence in the medical devices sector. Our company fosters a collaborative work culture that prioritises employee growth through continuous learning and development opportunities, ensuring you can thrive in your role. With a commitment to quality and innovation, we offer a supportive environment where your contributions directly impact our integration programme and overall success.

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Contact Details:

EPM Scientific Recruitment Team

We think you need these skills to ace Senior Regulatory Affairs – EU IVDR Perf. Studies (Remote)

Regulatory Affairs
Performance Study Applications
IVDR Documentation
Cross-Functional Collaboration
Project Coordination
Strategic Planning
Communication Skills