Ra & Qms Administrator - Part-time

Acumed Ltd.

Andover, Hampshire, United Kingdom
Part-time office based
Iso13485 compliance knowledge
Capa process management
Document control procedures
Acumed Ltd. is seeking a part-time RA & QMS Administrator to assist with the implementation and management of their Quality Management System in compliance with ISO13485. The role involves managing documentation, handling product complaints, and supporting regulatory compliance processes, all while being based in Andover, Hampshire

Job Summary

  • The role involves assisting the Regulatory & QMS Manager in planning and implementing the Quality Management policy to ensure ISO13485 compliance.
  • Responsibilities include managing product complaints, CAPAs, recalls, document control, and internal audits to ensure timely processing.
  • Candidates will work with global teams to harmonize UK and US quality management systems while maintaining accurate regulatory records.

Matching Summary

Match Score: 75

Acumed Ltd. is seeking a part-time RA & QMS Administrator to assist with the implementation and management of their Quality Management System in compliance with ISO13485. The role involves managing documentation, handling product complaints, and supporting regulatory compliance processes, all while being based in Andover, Hampshire.

Skills & Requirements

Must-have

  • ISO13485 compliance knowledge
  • CAPA process management
  • Document control procedures
  • Internal audit execution
  • Product recall administration

Nice-to-have

  • Cross-functional collaboration skills
  • Training staff on QMS processes
  • Experience with Activ software
  • Harmonizing UK and US QMS
  • Proactive stakeholder communication

Key Requirements

  • Experience with ISO13485 standards
  • Knowledge of medical device regulations
  • Proficiency in Activ (IL's) system
  • Ability to manage internal actions
  • Strong organizational and time management skills

Work Rights

Not specified

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