Medical Device Regulatory Compliance Manager

2 weeks ago


Galway City, Ireland Life Science Recruitment Ltd Full time

Job Description

We are looking for a Quality Manager to join our team at Life Science Recruitment Ltd. The successful candidate will have a strong background in quality assurance and regulatory compliance, with experience in the medical device or pharmaceutical industry.

The role will involve maintaining our client's Quality Management System (QMS), supervising quality technicians and engineers, and leading quality personnel in the completion of departmental activities.

Key Skills

  • Quality assurance and regulatory compliance experience;
  • Experience in the medical device or pharmaceutical industry;
  • Strong analytical skills and ability to work as part of a team;
  • Excellent communication and interpersonal skills;
  • Knowledge of ISO 13485 and 21 CFR 820 requirements;

Responsibilities

  1. Maintain and report on the performance of the QMS;
  2. Supervise quality technicians and engineers;
  3. Lead quality personnel in the completion of departmental activities;
  4. Oversee quality system, supplier control, manufacturing validation, customer complaints, CAPA/NCR, lot release, external audits, and operations support;


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