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Regulatory Compliance Specialist

2 weeks ago

Dublin, Dublin City, Ireland Brightwater Full time

At Brightwater, we are committed to maintaining the highest standards of quality, compliance, and continuous improvement. We are seeking a Regulatory Compliance Specialist to join our Quality Leadership Team and drive regulatory compliance initiatives.

About the Position

We are looking for a seasoned professional with 5+ years of experience in ISO 9001/2000 or ISO 13485 environments, preferably in Medical Devices or the Pharmaceutical industry. The successful candidate will be responsible for overseeing key regulatory compliance initiatives, including managing CAPAs and preparing for audits.

Key Responsibilities
  • Oversee key regulatory compliance initiatives, including managing CAPAs and preparing for audits.
  • Partner with production teams to drive continuous improvement initiatives using Six Sigma methodologies.
  • Ensure timely and compliant completion of CAPAs and maintain high-quality documentation.
  • Provide oversight and ensure GMP standards are consistently met in production and quality engineering activities.

Requirements

  • A third-level qualification in Engineering or a Science discipline is required; a postgraduate qualification in a related area is a plus.
  • At least 3 years of supervisory experience with a proven track record of team development.
  • Familiarity with Statistical Process Control and Six Sigma methodologies (Greenbelt Certification is a bonus).
  • Knowledge of FDA requirements and experience managing FDA audits.