Ra & Qms Administrator

Acumed Ltd.

United Kingdom
Not specified
Iso13485 compliance
Capa administration
Document control process
Acumed Ltd. is seeking a RA & QMS Administrator to support their Quality Management System and ensure compliance with ISO13485 and regulatory requirements. The role involves managing document control, CAPA processes, and product recalls, while working closely with the Regulatory & QMS Manager

Job Summary

  • The RA & QMS Administrator works with the Regulatory & QMS Manager to assist with the planning and implementation of the Quality Management policy and procedures and ensure compliance with ISO13485 and applicable regulatory requirements.
  • The role encompasses product and service complaints, CAPA’s, recalls, control of documents and internal audits so that they are processed/ completed in a timely manner.
  • Work with colleague at the manufacturing facilities in Addison and Hillsboro to implement relevant processes/ procedures to assist in harmonizing the UK QMS with that in the US.

Matching Summary

Match Score: 75

Acumed Ltd. is seeking a RA & QMS Administrator to support their Quality Management System and ensure compliance with ISO13485 and regulatory requirements. The role involves managing document control, CAPA processes, and product recalls, while working closely with the Regulatory & QMS Manager.

Skills & Requirements

Must-have

  • ISO13485 compliance
  • CAPA administration
  • document control process
  • internal audits
  • product and service complaints

Nice-to-have

  • positive impact on the world
  • diverse learning opportunities
  • empowered to be their best

Key Requirements

  • Regulatory & QMS Manager
  • Activ (IL’s)
  • MHRA Field Safe Notices
  • ComplianceWire learning management system

Work Rights

Not specified

Tailored Resume

Cover Letter