AI Medical Devices Regulatory Officer

Overview

AI Medical Devices Regulatory Officers shall carry out the following list of non-exhaustive activities:

• Author and maintain technical files in an organized and searchable way, ensuring documentation is current, consistent, and readily retrievable for submissions, updates, and external review.
• Provide support for assigned AI-enabled software medical devices (SaMD) within the Company’s portfolio of products, including but not limited to advice to engineering, AI/ML and clinical design teams on regulatory considerations for new products, features or changes.
• Support regulatory activities across international markets relevant to the Company’s portfolio, including but not limited to the US, EU and UK.
• Participate in risk management activities.
• Support post-market surveillance (PMS) activities, including vigilance reporting, Field Safety Corrective Actions (FSCA), and Periodic Safety Update Reports (PSURs), as needed.
• Support clinical evaluation activities and associated documentation (e.g., evidence collection, updates to clinical evaluation documentation, and claims substantiation).
• Maintain the list of registered devices and actors involved in the regulatory processes.
• Maintain the labelling register and support the review of labelling material including marketing claims, ensuring alignment with intended use and clinical evidence.
• Periodically assess the contents of Design History Files.
• Perform regular reviews of regulations, international standards and guidelines to highlight gaps and/or opportunities for continuous improvement of relevant technical documentation and the QMS, as well as support implementation with the subject specialists.
• Support the implementation and maintenance of the quality management system (QMS) in line with regulatory approvals and markets of interest for the Company’s software products.
• Interact with external parties, such as regulators, auditors, notified bodies, EUAR, end users, patients and external consultants on regulatory matters.

• Undergraduate degree in a relevant scientific or technical subject (e.g. software, biomedical engineering, biomedical sciences or similar).
• Qualification for the implementation of relevant regulatory standards and regulations (EU, UK, US).

• A minimum of five years working in the medical device regulatory industry.
• Knowledge of UK, EU and USA regulatory pathways, with practical experience supporting US regulatory activities strongly preferred.
• Experience or interest in topics relevant to AI-enabled devices, such as emerging AI regulation (e.g., EU AI Act) and/or cybersecurity/security considerations for medical devices / software.
• Strong digital skills are essential, including producing well-structured documents, maintaining trackers, and working efficiently with common documentation and collaboration tools, as well as an eQMS.