Clinical Regulatory Specialist

3 weeks ago

Dublin, 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 Duties
Clinical
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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