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.