Regulatory Affairs Manager
We are on a mission to help radiologists detect breast cancer earlier using deep learning.
Kheiron is a fast-growing, medical technology company that uses advanced machine learning to develop and deliver intelligent tools for radiologists, radiology departments, imaging centres and hospitals to improve the efficiency, consistency and accuracy of radiology reporting. We aim to save more lives by empowering radiologists in their role in diagnosis, treatment, and patient outcome.
Kheiron has offices in London, San Francisco, Budapest and the Netherlands. We are backed by Connect Ventures, Hoxton Ventures, Atomico, Greycroft and Exor Seeds.
We are proud that Kheiron is one of the winners of the first UK Government Artificial Intelligence (AI) in Health and Care Awards.
The funding will accelerate the roll out and rapid adoption of Mia (Mammography Intelligent Assessment) to address critical challenges in breast screening services.
We are looking for a talented Regulatory Affairs Manager to join our growing QARA Department at Kheiron. This is a really exciting role, reporting directly into our VP of RA/QA. This role will support our European and international expansion plans as we take our award winning AI products into new markets.
You will work collaboratively across the organisation to guide and support the departments in what is needed for regulatory clearance and will have hands-on involvement in submissions.
We have offices in the UK, US, Hungary and The Netherlands, and are open to candidate’s locations.
What you'll being doing:
- Be responsible for completing the submissions, the technical files and other regulatory dossiers
- Support and implement regulatory strategy and oversee the execution of this roadmap
- Keep abreast of current regulations that affect our products
- Review labels, literature, collateral and claims as requested
- Provide regulatory guidance to multiple different teams to ensure compliance with requirements
- Review competitive regulatory intelligence and provide update to team
- Coordinate post market surveillance activities
- Register products with health authority
We'd love you to join if you have:
- Extensive experience working as a Regulatory Affairs professional in the software as a medical device industry; a huge plus if it’s in radiology and/or AI
- Hands-on experience in co-ordinating successful regulatory submissions for class II devices in Europe and US Superb knowledge MDD/MDR, 21 cfr 820
- Technical file authoring experience (CE mark)
- Strong knowledge of ISO 13485, EN 62304, EN 82304, ISO 14791, ISO 14155, EN 62366
- Ability to review, explain and apply regulations
- Excellent organisation skills, attention to detail and ability to work on several simultaneous projects with tight timelines
- Effective problem solving and communication skills
It would great, but not essential, if you have:
- FDA 510(K) experience
- Radiological experience
- ROW experience
- Raps certification
What we offer:
- 🏥 Save Lives - be part of a team that changes the way patients are cared for
- 👨🎓👩🎓 Learner-centric Environment - We work in a fast-paced, high impact environment in which you can learn and grow your skill set
- 📈 Equity - We want you to be part of the Kheiron story and all employees will receive equity
- 🌴 Time Off: 22 days + the days between Christmas & New Year + 10 bank holiday days
- 🖥 Technology - Latest IT equipment as well as any accessories you may need
- ❤️ Health - We offer premium health coverage for you, your partner, and your children through Bupa
- 😌 Mental Health - We support mental health through Spill
- 👨👩👧👧 Enhanced Parental Leave - Extended maternity and paternity leave
At Kheiron we celebrate diversity and inclusion, we strive for a work environment in which all individuals are treated fairly and respectfully, have equal access to opportunities and resources, and can contribute fully to the organisation's success.
We are an equal opportunities employer and welcome everyone regardless of race, religion, gender, sexual orientation, age, disability, or marital status.