Clinical Regulatory Specialist

The Role

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:

oOne Team: working together to ensure the whole is greater than the sum of the parts

oPersonal Ownership: deliver on commitments

oOpen Communication: Honest open-minded communication

oFun: celebrate the successes

oContinuous Learning: at an individual and company level

oSolution Orientated: Identify problems but focus your energy on solutions

oQuality Focused: patient safety comes first

Essential Requirements

·Technical: Fundamental understanding and frequent application of quality principles for medical devices, ideally class III implantable devices. Knowledge of key Good Clinical Practice and Regulatory standards and their application.

·Problem Solving: Supports a culture of data-driven problem solving that ensure development of high-quality devices. This includes adherence to any systems / processes for robust data capture, analysis and presentation of information to guide the decision-making process.

·Project Management: Demonstrates project management & organisational skills. Ability to complete individual tasks on time.

·Initiative: Demonstrated ability to take initiative to prioritize work, reach business objectives and challenge task team decisions as required.

·People Skills: Demonstrates people skills to work effectively with others to achieve company goals.

·Communication: Effective verbal and written technical communication skills of technical information in a format appropriate for the understanding of others. Demonstrated effective presentation and group communication skills.

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

·Class III medical product development experience 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.