Join Eye2Gene as our Quality and Regulatory Affairs Manager (SaMD/ AIaMD)
Eye2Gene | London, UK (Paddington) | In person | £55,000–£75,000 DOE
Applicants must already have the right to work in the UK.
Eye2Gene is a VC-funded, AI-powered precision ophthalmology platform combining imaging and genomics to accelerate diagnosis and therapy development for genetic eye diseases worldwide. Our platform enables biotech and pharmaceutical companies, as well as eyecare professionals, to make data-driven decisions that bring sight-saving treatments to patients earlier. By integrating retinal imaging with genomic analysis, we aim to reduce the diagnostic odyssey patients face from years to weeks.
As a Class IIa Software as a Medical Device (SaMD), we are preparing for submission to our notified body for CE marking and ISO 13485 certification.
We’re looking for a Quality and Regulatory Affairs Manager to lead the development, implementation and continuous improvement of our Quality Management System (QMS), while supporting quality and regulatory readiness across the business. We are working with a leading regulatory consultancy that will provide specialist support and oversight, giving you the opportunity to play a central internal role as we progress towards CE marking and ISO 13485 certification.
This is a hands-on role with the opportunity to play a central role in building a high-quality, audit-ready software as a medical device organisation.
What you’ll do
- Lead the development, maintenance and improvement of the QMS in line with applicable standards and regulations
- Provide quality and regulatory input into technology and product development activities
- Support requirements capture, standards interpretation, clinical evaluation and documentation
- Drive hazard analysis, risk management and quality documentation activities
- Compile and maintain technical documentation and medical device file content where required
- Support interactions with notified bodies and regulatory authorities
- Ensure forms, records, registers and controlled documents are accurate and audit-ready
- Coordinate post-market surveillance, complaints handling and CAPA processes
- Support internal and external audits and follow-up actions
- Help define, monitor and improve Quality Objectives and KPIs
- Deliver QMS training to existing and new team members
What we’re looking for
- Experience in a Quality Assurance and/or Regulatory Affairs role within a regulated environment
- Strong working knowledge of ISO 13485
- Familiarity with ISO 9001, MDSAP, or similar quality standards
- Experience maintaining QMS processes and documentation
- Experience supporting audits, non-conformance management and CAPA activities
- Ability to work effectively across technical, product and operational teams
Desirable
- Experience with US FDA regulations, 21 CFR 820 and/or 21 CFR 11
- Experience working under EU MDR Article 10(9) or within a medical device QMS
- Experience with structured problem-solving methodologies such as 8D
- Experience in software and/or SaMD
- Experience in submitting to a Notified Body and Audits.
- Experience supporting CE marking and ISO 13485 certification
Qualifications
- Relevant degree, higher diploma or equivalent in science, engineering or a related field
- IRCA-certified or similar ISO 13485 Internal Auditor / Lead Auditor qualification is desirable
Why join Eye2Gene
- Work on technology with real potential to improve outcomes for patients with genetic eye disease
- Join a mission-driven, VC-backed company at the intersection of AI, genomics and ophthalmology
- Play a key role in shaping our quality systems and regulatory readiness as we scale
- Be part of the journey to CE marking and ISO 13485 certification
- Competitive salary: £55,000-£75,000, depending on experience
- Employee Shares Option Pool: potential for equity if milestones are met
To apply, please send your CV and a short cover note outlining your relevant experience and interest in the role.