X4 Life Sciences
Senior QARA Specialist
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Job Title: Quality and Regulatory Co-Ordinator
Salary: £40,000 - £45,000
Location: Essex, UK
Job Type: Permanent
A well-established medical device business is looking for an experienced Quality & Regulatory Co-Ordinator to join their team.
This is a hands-on, autonomous role suited to someone with 3–4+ years' experience within the medical device industry, who is confident managing QMS processes and supporting regulatory compliance.
Key Responsibilities:
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- Maintain and improve the ISO 13485 QMS
- Manage CAPA, NCRs and complaint investigations
- Oversee document and change control
- Maintain Technical Documentation for MDR / UKCA
- Support PMS and MHRA vigilance activities
- Manage supplier quality issues and SCARs
- Support internal and external audits
- Maintain training records and QMS documentation
- Conduct root cause analysis and effectiveness checks
Experience and Qualifications Required:
- 3–4+ years' experience in a medical device Quality or Regulatory role
- Strong knowledge of ISO 13485:2016
- Hands-on experience with CAPA, NCRs, complaints and QMS processes
- Experience supporting audits
- Strong organisational and problem-solving skills
- Able to work independently with minimal supervision
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How to apply:
Apply to e.smailes@x4lifesciences.com to learn more about the role or connect with me on LinkedIn to hear about regular job updates available with X4 Life Sciences.
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