Clinical Device Specialist

2 days ago

Sligo, Sligo, Ireland beBeeClinicalResearch Full time €70,000 - €90,000

Senior Clinical Research Associate

We are seeking a highly experienced professional to manage clinical studies for medical devices. This individual will work closely with our clinical team to develop innovative solutions.

  • Coordinate investigation activities, including staff management and supply ordering.
  • Collaborate with consultants and teams to ensure seamless study execution.
  • Maintain accurate records of study product logs and inventory.
  • Design and write protocols for preclinical & clinical studies, incorporating knowledge of quality management systems (QMS), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).
  • Conduct literature reviews and MAUDE searches to inform evaluations.
  • Develop and update certification, examination, proficiency and recognition documents (CEPs and CERs), ensuring compliance with regulatory requirements.

Required Skills and Qualifications:

  • Strong knowledge of QMS, GCP and GLP for medical devices and clinical studies.
  • Understanding of Class III device regulations in EU, US and globally (ISO 14155 and EU MDR 2017/745).
  • 5+ years' experience in clinical studies for medical devices ideal.
  • Cardiovascular experience ideal.
  • Fluent in English (and local language if different).
  • Familiar with device development from pre-clinical to commercial stage.
  • Knowledge of GCP in US and EU.
  • High attention to detail.

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