Ra & Qms Administrator

Acumed Ltd.

**
Iso13485 compliance
Capa administration
Document control process
** Acumed Ltd. is seeking a Regulatory Affairs and Quality Management System (RA & QMS) Administrator to assist in implementing and maintaining quality management policies and procedures while ensuring compliance with ISO13485 and regulatory requirements. This role involves managing documents, internal audits, product complaints, and recalls, and requires collaboration with various stakeholders to ensure timely and effective operations. **

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 Regulatory Affairs and Quality Management System (RA & QMS) Administrator to assist in implementing and maintaining quality management policies and procedures while ensuring compliance with ISO13485 and regulatory requirements. This role involves managing documents, internal audits, product complaints, and recalls, and requires collaboration with various stakeholders to ensure timely and effective operations. **

Skills & Requirements

Must-have

  • ISO13485 compliance
  • CAPA administration
  • document control process
  • internal audits
  • product recalls
  • MHRA Field Safe Notices monitoring

Nice-to-have

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

Key Requirements

  • Regulatory & QMS Manager assistance
  • Activ (IL’s) administration
  • product registration assistance
  • training staff

Work Rights

Not specified

Tailored Resume

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