At a Glance
- Tasks: Lead the development and improvement of our Quality Management System in a dynamic environment.
- Company: Join Eye2Gene, a VC-funded AI-powered precision ophthalmology platform.
- Benefits: Competitive salary, employee shares option pool, and a chance to make a real impact.
- Other info: Be part of a mission-driven team at the forefront of AI and genomics.
- Why this job: Shape quality systems and regulatory readiness for life-changing technology.
- Qualifications: Experience in Quality Assurance or Regulatory Affairs within a regulated environment.
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 in London 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 in London
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend relevant events, and connect with people 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 Eye2Gene and understanding their mission. Be ready to discuss how your experience aligns with their goals, especially around quality management and regulatory affairs. Show them you’re not just another candidate!
✨Tip Number 3
Practice common interview questions related to quality assurance and regulatory affairs. Think about specific examples from your past roles that demonstrate your skills and achievements. Confidence is key, so rehearse until you feel ready to shine!
✨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 genuinely interested in joining the Eye2Gene team. Let’s get you that dream job!
We think you need these skills to ace Quality and Regulatory Affairs Manager in London
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, explaining why you're passionate about quality management in the medical device field. Let us know how your skills can help us achieve CE marking and ISO 13485 certification.
Showcase Relevant Experience:When detailing your experience, focus on specific projects or roles where you’ve led QMS development or supported audits. We love seeing concrete examples of how you've contributed to quality assurance in a regulated environment.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. We can't wait to hear from you!
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. Be ready to discuss how you've applied these in your previous roles, especially in a regulated environment. This shows you're not just familiar with the standards but can also implement them effectively.
✨Showcase Your Hands-On Experience
Prepare examples from your past work where you led QMS development or supported audits. Highlight specific challenges you faced and how you overcame them. This will demonstrate your practical knowledge and problem-solving skills, which are crucial for this role.
✨Understand the Regulatory Landscape
Familiarise yourself with the CE marking process and the role of notified bodies. Being able to articulate your understanding of these processes will set you apart. If you have experience with US FDA regulations, be sure to mention that too!
✨Be Ready for Scenario Questions
Expect questions that assess your ability to handle real-world situations, like managing non-conformance or CAPA activities. Think through some scenarios beforehand and prepare your responses. This will help you feel more confident and articulate during the interview.
