Senior Medical Device Coordinator

18 hours ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time

Job Title: Clinical Regulatory Specialist

**Clinical and Regulatory Role Summary:**

As a highly skilled Clinical Regulatory Specialist, you will play a critical role in supporting the development of cutting-edge structural heart devices.

The ideal candidate will possess a strong understanding of quality principles for medical devices and be able to coordinate global clinical trial execution while ensuring compliance with regulatory standards.

Key Responsibilities:

  • Coordinate and support activities related to global clinical trial execution, including site activation, enrolment, follow up and closure, in accordance with the study schedule.
  • Communicate the study status and timelines and escalate unresolved issues appropriately to line manager.
  • Support the development of study documents, including study protocols and Investigator's Brochure and regulatory submission deliverables.
  • Assist in maintenance of the clinical study electronic database and clinical data structure ensuring update to data and accurate information is readily available.
  • Support trial/regional enrolment strategy and execution.
  • Oversee clinical product inventory and the timely supply of all materials to clinical sites.
  • Support management of essential documents and Trial Master File, ensuring inspection-readiness. Identify and assist in developing continuous improvement activities.

Required Skills and Qualifications:

  • Strong understanding of quality principles for medical devices and regulatory requirements.
  • Excellent project management and organizational skills.
  • Ability to communicate technical information effectively and make presentations to various audiences.
  • Proven ability to work effectively in a team environment and prioritize tasks to meet deadlines.
  • Degree or master's degree in science or engineering, or related disciplines.
  • Experience in medical device Clinical Affairs or Regulatory Affairs preferred.

Benefits:

  • Opportunity to work on cutting-edge medical devices.
  • Chance to develop your skills and knowledge in clinical and regulatory affairs.
  • Collaborative and dynamic work environment.

Others:

This role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned from time to time.

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