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Senior Quality Systems Specialist

2 weeks ago

Sligo, Sligo, Ireland beBeeQuality Full time €100,000 - €120,000
Job Overview

This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745.

  • Serve as the PRRC for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
  • Host external audits in the EU region, demonstrating quality management system compliance to external regulators.
  • Conduct internal audits to assess the compliance of quality management system.

Maintain expertise in current and emerging regulations and standards impacting medical device and combination products.



Responsibilities:
  1. Lead root cause investigation and corrective action planning in response to audit observations.
  2. Analyze and interpret quality system performance metrics.
  3. Program-manage initiatives to improve and globalize the quality management system.
Requirements:
  • Bachelor's degree in engineering, physical science, life science, or pharmacy, with a minimum of 7 years of industry experience in a GXP regulated environment.
  • ISO 13485 Lead Auditor certification is preferred.

This is a hybrid role with 3 days on site, 2 days remote.