Regulatory Affairs Specialist

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

Picture yourself at one of the world's most innovative companies, providing life‑saving AI solutions that can make a real difference in helping to combat one of the world's biggest health burdens. Surrounded by teams and people who challenge you, support you, and inspire you to be extraordinary. Are you ready to join the fight against heart failure?

We are redefining Cardiovascular Medicine दस्त through transformational AI solutions and work alongside major collaborations such as Mayo Clinic and the NHS England, with one shared ambition, to save lives. Ultromics is a global leader in AI‑powered cardiovascular imaging diagnostics amap how heart disease is detected, assessed, and managed. Spun out from the University of Oxford, UK and built on a decade of world‑leading research, Ultromics is redefining echocardiography with solutions that deliver actionable insights to clinicians and healthcare systems. EchoGo® leverages advanced FDA cleared AI diagnostics to unlock complex cardiovascular conditions, including heart failure, cardiac amyloidosis, and more. We have established a world‑class clinical evidence base with over 25 peer‑reviewed publications, global collaborations with leading academic institutions and healthcare providers, and pivotal partnerships with life sciences organisations focused on drug development and commercialisation. Ultromics is backed by some of the world’s most influential healthcare and technology VC investors, including Google Ventures (GV), Optum Ventures (UnitedHealth Group), Blue Venture Fund (Blue Cross Blue Shield), and other leading U.S. and U.K.‑based funds. These strategic partnerships accelerate our access to healthcare systems, payers, and lifelb sciences organisations, and support our ambition to reshape cardiovascular care on a global scale. Our platform is poised to become the standard in AI‑driven cardiovascular diagnostics, enabling better outcomes for patients and more efficient care delivery for providers.

Why Join Us?

• Be part of a mission‑led company tackling one of the world’s biggest osl health challenges: heart failure.
• Contribute to cutting‑edgeطورة AI technologies backed by robust research, regulatory clearances, and reimbursement pathways.
• Collaborate with a passionate, multi‑disciplinary team of clinicians, scientists, engineers, and commercial experts.
• Work at the intersection of healthcare, AI, and medical imaging with opportunities to shape the future of diagnostics.
• Join us and help change the future of heart health — making cardiovascular disease more detectable, treatable, and survivable for patients everywhere.

Your Role

We are seeking a Regulatory Affairs Specialist with hands‑on experience in Software as a Medical Device (SaMD) and AI/ML‑enabled medical technologies. The specialist will prepare CE mark technical documentation, review technical files for compliance, contribute to FDA submissions, and manage post‑market regulatory activities including PMS, PSUR, vigilance reporting, and regulatory intelligence monitoring. This role ensures both pre‑market and post‑market regulatory compliance, working across EU and US frameworks.

Your Responsibilities

• Prepare CE mark technical documentation in accordance with EU MDR (2017/745).
• Review and maintain technical files, ensuring completeness, accuracy, and readiness for notified body review.
• Support preparation and validation stimulation of Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs).
• Contribute to FDA submissions (510(k), De Novo, PMA, IDE) by preparing maneuvering regulatory sections and supporting evidence.
• Review and support clinical research and clinical investigation submissions (EU/UK and FDA), including applications, amendments, and progress reports.
• Collaborate with Data Science and Clinical teams to verify regulatory evidence for AI/ML algorithms (validation, performance monitoring, bias mitigation).
• Support interactions with notified bodies (EU) and FDA (US).
• Support preparation and management of Post‑Market Surveillance (PMS) and Post‑Market Clinical Follow‑up (PMCF) activities, ensuring findings are integrated into CERs and risk management files.
• Prepare, review, and maintain PSURs (Periodic Safety Update Reports) in compliance with MDR timelines.
• Handle vigilance reporting, including adverse event reporting and Field------ Safety Corrective Actions (FSCA), in line with EU MDR and FDA 21 CFR Part 803 (MDR reporting).
• Maintain vigilance tracking logs and ensure timely reporting to Competent Authorities and FDA (MDR/MDUFMA requirements).
• Monitor and interpret regulatory intelligence (EU MDR, EU AI Act, IMDRF SaMD guidance, FDA GMLP, SaMD PCCPs) and communicate implications to internal stakeholders.
• Support MDR QMS maintenance and periodic review, ensuring alignment with ISO 13485 and MDR requirements.
• Collaborate with Quality Assurance to update SOPs, work instructions, and templates covering PMS, vigilance, PSUR, and technical documentation.
• Participate in internal audits, management reviews, and notified body audits as the RA representative.
• Ensure that QMS processes reflect current regulatory expectations for SaMD and AI/ML devices.
• Follow good information governance practice throughout this job role and ensure compliance with Ultromics’ information security and data protection policies in all applicable assigned tasks.
• This list of duties is not exhaustive, and the post holder may be asked to carry out lia arc duties through discussion with their line manager.

Requirements

Your skills and experience:

• Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Computer Science, Regulatory Affairs, or related discipline (or relevant equivalent experience).
• 3–5+ years regulatory experience in the SaMD medical device industry, including preparing CE mark technical documentation and reviewing technical files; supporting FDA submissions (510(k), PMA, IDE, De Novo); and managing PMS/PSUR and vigilance reporting processes.
• Strong understanding of EU MDR (2017/745), MEDDEV 2.7/1 Rev. 4, ISO 13485, ISO 14971, ISO 14155, and IEC 62304.
• Experience with SaMD/AI/ML devices, including regulatory considerations for algorithm performance and software updates.
• Excellent regulatory writing and documentation review skills.

Your desired skills and experience:

• Experience in a venture capital‑backed start‑up or scale‑up environment.
• Proven track record of supporting regulatory submissions in the EU, UK, and/or US markets.
• Experience collaborating cross‑functionally with R&D, Quality, Clinical, Product and Commercial teams.
• Strong understanding of software and AI medical device regulations, including MDR, and/or FDA 21 CFR Part 820.
• Familiarity with regulatory software tools, document control systems, and eQMS platforms.

We are committed to promoting work‑life balance and offer a range of benefits to encourage this, including:

• Hybrid working options
• PMI & cash plan
• Life assurance
• Two additional paid Company holidays in December (if they fall on Monday‑Friday)
• Two paid volunteering days per year
• Wellness benefit
• 5% company pension contribution
• Employee referral reward
• Generous personal learning budget on our online learning marketplace, Learnerbly
• Cycle Scheme
• A well‑stocked kitchen with free snacks - and great coffee!

Our Values

• Prioritising Patients: Everything we do is focused on improving patients’ lives - through earlier diagnosis, better pathways to treatment, and meaningful clinical outcomes.
• Scientific Integrity: We are evidence‑led and clinically grounded. We pursue truth over convenience, upholding the highest standards of precision, validation and transparency.
• Bold Innovation: We challenge convention, embrace complexity, and push boundaries to transform cardiovascular diagnostics through AI.
• Commitment and Craft: We show up with purpose, work hard, and take pride in our impact.
• Kindness and Respect: We treat each other, our partners, and our users with consideration and empathy.