Clinical Regulatory Specialist

1 week ago

Dublin, Dublin City, Ireland CroíValve Full time

Support the product development of a cutting-edge structural heart device through design development, verification, clinical trials, validation and regulatory approval.

Reporting Lines

Reports to Clinical and/or Regulatory Manager

Key responsibilities and DutiesClinical
  • 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.
Regulatory
  • Support compliance to all internal and external regulatory requirements.
  • Review and assessment of changes affecting clinical investigations, including product design, manufacturing, labeling, and clinical protocol, working with cross-functional teams.
  • Coordinate and prepare regulatory submissions for clinical and commercial applications, as applicable.
  • Preparation of annual progress reports relating to on-going clinical investigations.
  • Interpret new or revised medical device regulations and standards, develop internal procedures to ensure continuous compliance with all regulatory requirements.
  • Ensure interactions with colleagues/stakeholders fully reflects the company values:
    • One Team: working together to ensure the whole is greater than the sum of the parts
      • Personal Ownership: deliver on commitments
        • Open Communication: Honest open-minded communication
          • Fun: celebrate the successes
            • Continuous Learning: at an individual and company level
              • Solution Orientated: Identify problems but focus your energy on solutions
Education and Experience
  • Degree or master's degree in science or engineering, or related disciplines
  • Experience in medical device Clinical Affairs or Regulatory Affairs preferred
  • Working knowledge of FDA, GMP, QSR and ISO 13485 requirements preferred
  • Experience preparing clinical study and technical documentation preferred
  • Excellent communication, organisational and time management skills

Availability to travel is required

The above 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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