Regulatory Affairs Specialist - SaMD/AI (Cardio)

Ultromics Limited; Oxford; Hybrid; GBP 50,000 - GBP 70,000; Full time

Job summary

A leading AI healthcare technology company in Oxford is seeking a Regulatory Affairs Specialist responsible for preparing regulatory documentation and ensuring compliance with EU and US regulations for software as a medical device (SaMD). The role involves collaboration with cross-functional teams and offers opportunities to impact the regulatory landscape in cardiovascular diagnostics utilizing AI technologies. Applicants should have 3-5 years of regulatory experience and a strong understanding of relevant regulations.

Benefits

Hybrid working options

PMI & cash plan

Life assurance

Two additional paid Company holidays in December

Wellness benefit

5% company pension contribution

Generous personal learning budget

Cycle Scheme

Free snacks and great coffee

Qualifications

• 3–5+ years regulatory experience in the SaMD medical device industry.
• Experience with FDA submissions including 510(k) and PMA.
• Strong understanding of regulatory considerations for AI/ML devices.

Responsibilities

• Prepare CE mark technical documentation in accordance with EU MDR.
• Review and maintain technical files for compliance.
• Support FDA submissions and interactions with data science teams.

Skills

Regulatory writing

Technical file review

Understanding of EU MDR

Experience in SaMD

Education

Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, or related

Job description

A leading AI healthcare technology company in Oxford is seeking a Regulatory Affairs Specialist responsible for preparing regulatory documentation and ensuring compliance with EU and US regulations for software as a medical device (SaMD). The role involves collaboration with cross-functional teams and offers opportunities to impact the regulatory landscape in cardiovascular diagnostics utilizing AI technologies. Applicants should have 3-5 years of regulatory experience and a strong understanding of relevant regulations.