Senior AI Medical Devices Regulatory Officer

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

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.