Quality & Regulatory Co-ordinator

Location: Essex (Office-Based)
Salary: £35,000–£45,000 (depending on experience)

The Role

An established medical devices organisation supplying UK and international markets is seeking a Quality & Regulatory Co-ordinator to take ownership of key Quality and Regulatory activities. This is a hands-on role suited to an experienced professional who can manage QMS processes, support regulatory compliance, and maintain audit readiness with minimal supervision.

Key Responsibilities

• Maintain and improve the ISO 13485 Quality Management System
• Manage document control, change control, CAPA, NCRs, and complaints
• Maintain Technical Files in line with MDR and UKCA requirements
• Support Post-Market Surveillance and vigilance reporting
• Manage supplier quality issues and SCARs
• Support internal and external audits
• Maintain training records and support QMS training
• Act as a point of contact for quality and regulatory queries

Requirements

• 3–4 years’ experience in a medical device Quality and/or Regulatory role
• Strong working knowledge of ISO 13485
• Hands-on experience with CAPA, complaints, QMS documentation, and audits
• Highly organised, detail-focused, and able to work autonomously

Desirable: Experience with MDR, UKCA, MHRA vigilance, EUDAMED, or electronic QMS systems.

Profile

• Independent, proactive, and confident managing responsibilities
• Strong problem-solving and root cause analysis skills
• Clear communicator across internal teams and external stakeholders

Eligibility

• Applicants must have full, unrestricted Right to Work in the UK
• Visa sponsorship is not available for this role

Note: This is not an entry-level or administrative position. Candidates must have proven, hands-on experience within a regulated medical device environment.