The Regulatory Affairs specialist will support the product development of a cutting-edge structural heart device through design development, verification, clinical trials,validation and regulatory approval.
Role and responsibilities:
- Support the creation & maintenance of product design and technical documentation in compliance with the relevant regulations and standards (Class III, animal derived, implantable devices). This includes providing guidance to and coordinating inputs from the technical experts on each design project.
- Support the development and submission of high quality clinical and regulatory files to the relevant ethical committees and regulatory agencies, ensuring successful approval.
- Organise and maintain regulatory and clinical submissions with regulatory authorities, ethical committees, and clinical investigation sites.
- Co-ordinate and, where appropriate, conduct gap assessment activities in line with updated regulatory requirements and standards.
- Keep up to date with changes in applicable regulatory requirements and standards.
- Assist company preparation for inspection by notified body and regulatory authorities.
- Support implementation and maintenance of a robust and fully compliant quality system in accordance with ISO 13485, including risk management.
- Continuous improvement of the Quality Management System to meet the requirements of all stakeholders.
- Co-ordinate and progress Adverse Event reporting to regulatory authorities as required by QA/RA Manager.
- Administrate the processes for the control of product information, including labelling, Instructions For Use (IFU), and user training.
- Ensuring adherence to all organisational and external regulatory requirements.
- Bachelor's or master's degree in science or related disciplines.
- Minimum of two (2) years of related experience in Regulatory Affairs, Quality or Design Assurance.
- Experience of preparing technical documentation for submission to regulatory agencies.
- Class III medical device experience is preferred.
- Working knowledge of GMP, FDA QSR and ISO 13485 requirements.
- Previous auditing experience preferred.
- Excellent communication, organisational and time management skills
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.