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Medical Devices Compliance Specialist

2 weeks ago

Mullingar, Ireland beBeeRegulatory Full time €55,522 - €81,130
Regulatory Quality Expert

We are seeking a highly skilled Regulatory Quality Expert to contribute to high-profile projects in a regulated environment.

Main Responsibilities:
  • Develop and implement quality improvement initiatives to enhance processes, reduce costs, and ensure regulatory compliance.
  • Sustain change controls, risk assessments, and process validations.
  • Analyse data and identify trends using statistical tools.
  • Author and review CAPAs, non-conformance reports, and supplier corrective actions.
  • Perform audits and support inspections by ISO and FDA regulators.
  • Collaborate with cross-functional teams to embed best practices in quality standards.
Necessary Skills and Qualifications:
  • Minimum 3 years of experience in a regulated environment - preferably medical devices or FDA/ISO 13485 certified manufacturing.
  • Degree in Quality, Science, or Engineering.
  • Advanced MS Excel, Word, and PowerPoint skills.
  • Familiarity with FMEAs, root cause analysis, and statistical analysis.
  • Excellent attention to detail and problem-solving ability.