Senior Regulatory Affairs Specialist
CroíValve are looking for a Senior Regulatory Affairs Specialist to support the product development of a cutting-edge structural heart device through design development, verification, clinical trials, validation and regulatory approvals.
This position can be fully remote.
Key Responsibilities and Duties
Provide regulatory guidance to product development team, working closely with cross-functional team members to develop and implement the regulatory strategy.
Lead the development, submission and maintenance of high quality clinical and regulatory files to the relevant ethical committees and regulatory agencies, ensuring successful approval.
Support the creation and maintenance of product design and technical documentation in compliance with the relevant regulations and standards (Class III, animal derived, implantable devices).
Assess and support design and process changes with cross-functional team members, ensuring completion of all associated regulatory activities.
Keep up to date with changes in applicable regulatory requirements and standards, and where appropriate coordinate and/or conduct gap assessment activities.
Participate in discussions with regulatory authorities.
Assist company preparation for inspection by notified body and regulatory authorities.
Support implementation and continuous improvement of a robust and fully compliant quality system in accordance with ISO 13485, including risk management.
Administrate the processes for the control of product information, including labelling, Instructions For Use (IFU), and user training.
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
-Quality Focused: patient safety comes first
Education and Experience
Bachelor’s or master’s degree in science or related disciplines
Minimum of five (5) years of related experience in Regulatory Affairs
Experience preparing technical documentation for submission to regulatory agencies
Class III medical device experience preferred
Clinical trial experience preferred
Working knowledge of GMP, FDA QSR and ISO 13485 requirements
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.