AI Medical Devices Regulatory Officer

Odin Vision Ltd; United Kingdom; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading medical technology firm in the United Kingdom is seeking an AI Medical Devices Regulatory Officer with extensive experience in regulatory affairs. The ideal candidate will have at least five years in the medical device industry and strong skills in regulatory pathways in the UK, EU, and US. Responsibilities include maintaining technical files, supporting AI-enabled software medical devices, and engaging with regulators. A relevant undergraduate degree is required, along with knowledge of emerging AI regulations.

Qualifications

• A minimum of five years in the medical device regulatory industry.
• Knowledge of UK, EU and USA regulatory pathways.
• Experience with emerging AI regulation and cybersecurity for medical devices.

Responsibilities

• Maintain technical files and ensure documentation is current.
• Support regulatory activities for AI-enabled software medical devices.
• Participate in risk management activities.
• Support post-market surveillance activities.
• Maintain labeling register and review labeling material.
• Assess content of Design History Files regularly.

Skills

Regulatory knowledge (EU, UK, US)

Strong digital skills

Experience with AI-enabled devices

Education

Undergraduate degree in a relevant scientific or technical subject

Tools

eQMS

Job description

Desirable Qualifications

• 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).

Experience

• 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.

AI Medical Devices Regulatory Officers

• 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 (FSCAs), 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.