Quality and Regulatory Affairs Manager

Eye2Gene; Greater London; On-site; GBP 50,000 - 70,000; Full time

Job summary

Eye2Gene is looking for an experienced Quality and Regulatory Affairs Manager in Greater London to develop and maintain their Quality Management System (QMS) in compliance with standards like ISO 13485. The role includes providing regulatory input, managing documentation, and supporting audits. The ideal candidate has a proven background in quality assurance or regulatory affairs within a regulated environment, strong knowledge of relevant standards, and experience with CAPA activities. This position offers the chance to build a high-quality software as a medical device organisation.

Qualifications

• 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.

Responsibilities

• 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.
• 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.

Skills

Quality Assurance experience

Regulatory Affairs knowledge

ISO 13485 knowledge

ISO 9001 familiarity

Auditing support

CAPA activities

Job description

Join Eye2Gene as our Quality and Regulatory Affairs Manager (SaMD/ AIaMD)

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, 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