Our client a medical device start up are looking for a Senior Regulatory Affairs Specialist to support the product development of a cutting-edge device through design development, verification, clinical trials, validation and regulatory approvals. This position can be fully remote.


Role/Responsibilities

• 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

• 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