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:
o One Team: working together to ensure the whole is greater than the sum of the parts
o Personal Ownership: deliver on commitments
o Open Communication: Honest open-minded communication
o Fun: celebrate the successes
o Continuous Learning: at an individual and company level
o Solution Orientated: Identify problems but focus your energy on solutions
o Quality 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.