At a Glance
- Tasks: Lead quality management and regulatory compliance for innovative AI-powered medical devices.
- Company: Join Eye2Gene, a mission-driven, VC-backed tech company in London.
- Benefits: Competitive salary, employee share options, and the chance to make a real impact.
- Other info: Be part of a dynamic team working towards CE marking and ISO 13485 certification.
- Why this job: Shape quality systems that improve patient outcomes in genetic eye disease.
- Qualifications: Experience in Quality Assurance or Regulatory Affairs within regulated environments.
The predicted salary is between 55000 - 75000 £ per year.
Join Eye2Gene as our Quality and Regulatory Affairs Manager (SaMD/ AIaMD) in London, UK (Paddington). 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.
Quality and Regulatory Affairs Manager employer: Eye2Gene
Eye2Gene is an exceptional employer, offering a unique opportunity to work at the forefront of AI-powered precision ophthalmology in London. With a strong focus on employee growth and a collaborative work culture, you will play a pivotal role in shaping quality systems and regulatory readiness while contributing to life-changing technology for patients with genetic eye diseases. Enjoy competitive salaries, potential equity through our Employee Shares Option Pool, and the chance to be part of a mission-driven team dedicated to making a real impact in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Quality and Regulatory Affairs Manager
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend relevant events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their mission and how your skills can contribute to their goals. This will help you stand out and show that you're genuinely interested in the role.
✨Tip Number 3
Practice common interview questions and tailor your answers to highlight your experience in Quality Assurance and Regulatory Affairs. Use specific examples from your past roles to demonstrate your expertise and problem-solving skills.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining Eye2Gene and being part of our mission to improve patient outcomes.
We think you need these skills to ace Quality and Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality and Regulatory Affairs Manager role. Highlight your experience with ISO 13485 and any relevant regulatory affairs roles you've held. We want to see how your background aligns with our mission at Eye2Gene!
Craft a Compelling Cover Note:Your cover note is your chance to shine! Keep it short but impactful, outlining your relevant experience and why you're excited about joining Eye2Gene. We love seeing genuine enthusiasm for our mission in your application.
Showcase Your Skills:Don’t forget to showcase your skills in quality management systems and regulatory compliance. Mention specific projects or achievements that demonstrate your expertise. We’re looking for someone who can hit the ground running!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications better and ensures you don’t miss out on any important updates from us. Let’s get started on this journey together!
How to prepare for a job interview at Eye2Gene
✨Know Your Standards
Make sure you brush up on ISO 13485 and any other relevant quality standards before the interview. Being able to discuss how these standards apply to Eye2Gene's work will show that you're not just familiar with the regulations, but that you can actively contribute to their implementation.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed QMS processes or supported audits. Highlighting your hands-on experience with CE marking and ISO certification will demonstrate your capability to lead in this role.
✨Understand the Company’s Mission
Familiarise yourself with Eye2Gene's mission and how their AI-powered platform works. Being able to articulate how your role as a Quality and Regulatory Affairs Manager fits into their vision will set you apart as a candidate who truly understands the company.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's current challenges in regulatory affairs or their plans for future product development. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
