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Device Assurance Specialist

2 weeks ago


Dublin, Dublin City, Ireland beBeeDevice Full time €70,000 - €90,000
Job Title: Device Assurance SpecialistEnsure Medical Device Compliance and Development ExcellenceJob Description:

This role is focused on guaranteeing adherence to design control requirements during medical device development. You will collaborate closely with cross-functional teams to develop innovative device technologies for drug delivery.

  • Provide guidance on Design History Files and associated activity plans and timelines.
  • Collaborate with stakeholders to establish objective evidence and controls.
  • Support integration and assess compliance of acquired combination products and medical devices into the Global Device Development portfolio.
  • Maintain awareness of industry best practices and implement improvement actions.
  • Participate in audits, including health authority and certification body audits.

About This Role:

  • You require a degree or masters in engineering or science/life science.
  • Proven experience in similar roles/general experience in the medical device or pharmaceutical industry.
  • Demonstrated understanding of GMP, Quality Management System, and relevant regulations and international standards.
  • Strong problem-solving and analytical skills, with excellent communication and teamwork abilities.