Join Eye2Gene as our Quality and Regulatory Affairs Manager (SaMD/ AIaMD) 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.
Provide quality and regulatory input into technology and product development activities 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 Coordinate post-market surveillance, complaints handling and CAPA processes Help define, monitor and improve Quality Objectives and KPIs Deliver QMS training to existing and new team members
Experience in a Quality Assurance and/or Regulatory Affairs role within a regulated environment Familiarity with ISO 9001, MDSAP, or similar quality standards Experience supporting audits, non-conformance management and CAPA activities Experience working under EU MDR Article 10(9) or within a medical device QMS Experience in software and/or SaMD Relevant degree, higher diploma or equivalent in science, engineering or a related field Play a key role in shaping our quality systems and regulatory readiness as we scale Competitive salary: £55,000-£75,000 , depending on experience…