Ra & Qms Administrator

Acumed Ltd.

Not specified (assumed hybrid or onsite based on industry norms)
Quality management policy and procedures
Iso13485 compliance
Product and service complaints
Acumed Ltd. is seeking a Regulatory Affairs and Quality Management System (RA & QMS) Administrator to support their compliance efforts with ISO13485 and regulatory requirements. This role involves managing document control, handling CAPA processes, and assisting with product recalls and complaints to enhance the overall quality management system

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: 85

Acumed Ltd. is seeking a Regulatory Affairs and Quality Management System (RA & QMS) Administrator to support their compliance efforts with ISO13485 and regulatory requirements. This role involves managing document control, handling CAPA processes, and assisting with product recalls and complaints to enhance the overall quality management system.

Skills & Requirements

Must-have

  • Quality Management policy and procedures
  • ISO13485 compliance
  • product and service complaints
  • CAPA administration
  • document control process
  • internal audits

Nice-to-have

  • positive impact on the world
  • diverse learning opportunities
  • empowered to be their best
  • harmonizing UK QMS with US

Key Requirements

  • ISO13485
  • MHRA Field Safe Notices
  • Activ (IL's)
  • ComplianceWire learning management system

Work Rights

Not specified

Tailored Resume

Cover Letter