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.