Senior Regulatory Affairs Specialist


Our client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the relevant Regulatory and Notified Bodies. They will also be required to help maintain the Design History Fileof Class III implant. This position offers the opportunity to join in an exciting early stage company developing a novel cardiovascular device


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 Director.
• 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 degree in science, engineering or related field
• Proven track record in a similar role with a minimum of 5 years in medical device Regulatory Affairs
• Extensive knowledge of quality management systems, design controls per ISO 13485 and current International and European regulations/standards with respect to medical devices.
• In depth knowledge of the EU Medical Device Directive and MEDDEV guidance documents
• Experience in design, verification and process validation processes
• Prior experience and knowledge in GMP, process validation, change control, CAPA and electronic document control systems
• Prior experience in class III medical products highly preferred
• Prior experience in a medical device start up preferred.
• Good leadership and project management skills with the ability and willingness to effectively build and manage a small team. Experience in people management and development.
• Excellent verbal and written communication skills