RA & QA Associate — IVD Regulation & Quality

Signatur Biosciences

Greater London

On-site

GBP 55,000 - 70,000

Full time

41 hours ago
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Benefits offered by this job

One-to-one mentoring
Travel to Liège laboratory
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Job summary

Signatur Biosciences in London, UK is seeking a hands-on Regulatory Affairs & Quality Assurance Officer at an early career stage to support ISO 13485 and IVDR compliance for our qPCR‑based diagnostics.

You will work under the Head of RAQA, gain practical experience across audits, documentation, and QMS maintenance, and travel to our Liège laboratory as needed in a fast-paced startup environment.

Qualifications

  • Bachelor’s or master’s degree in a life-science field or related discipline.
  • Fluent in English, written and spoken; precise writer.
  • Strong attention to detail and methodical documentation.
  • Self-starter with initiative; comfortable in a fast-paced startup environment.

Responsibilities

  • Support ISO 13485 and IVDR conformity through documentation and audits.
  • Draft and maintain SOPs, forms, templates, and training records.
  • Assist with regulatory intelligence, cross-referencing, and technical documentation.
  • Contribute to QMS improvement and participate in internal audits.

Skills

Attention to detail
Strong written English
Organization
Quick learner
Initiative
Team collaboration

Education

Bachelor’s or Master’s degree in life sciences

Job description

Signatur Biosciences in London, UK is seeking a hands-on Regulatory Affairs & Quality Assurance Officer at an early career stage to support ISO 13485 and IVDR compliance for our qPCR‑based diagnostics.

You will work under the Head of RAQA, gain practical experience across audits, documentation, and QMS maintenance, and travel to our Liège laboratory as needed in a fast-paced startup environment.

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