We are a team on a mission, to put accessible and affordable healthcare in the hands of every person on earth. Our mission is bold and ambitious, and it’s one that’s shared by our team who shares our values, to dream big, build fast and be brilliant.
To achieve this, we’ve brought together one of the largest teams of scientists, clinicians, mathematicians and engineers to focus on combining the ever-growing computing power of machines, with the best medical expertise of humans, to create a comprehensive, immediate and personalized health service and make it universally available.
babylon was included in WIRED’s 2016 Top 100 Hottest Startups in Europe and CB Insights 2017 Global ‘AI 100’ list. Fortune Magazine included babylon in their 2017 list of ’50 Companies Leading the AI Revolution’, the only listed company using AI in healthcare delivery.
At babylon our people aren’t just part of a team, they’re part of something bigger. We’re a vibrant community of creative thinkers and doers, forging the way for a new generation of healthcare.
We’re only as good as our people. So, finding the best people is everything to us. We serve millions, but we choose our people one at a time…Role / Responsibilities
Coordinate all activities related to domestic and regulatory submission and approval for medical software solutions.
Drive regulatory strategy for domestic and international markets assuring early consideration of regulatory requirements.
Support the product development teams in the implementation of regulatory requirements, including preparation and review of design and test documentation.
Prepare, coordinate, and file regulatory submission documents.
Perform regulatory assessment of product changes.
Review and approve marketing materials to ensure compliance with advertising and promotional regulations.
Prepare, or contribute to the preparation of post-market surveillance plans and evaluate post-market data.
Ensure regulatory requirements are met for maintenance of products.
Support internal and external audits.
Research and evaluate different risk factors regarding business decisions and operations.
Stay abreast of current and novel developments in the field.
As part of a new start-up with a highly collaborative culture, perform other related duties and “pitch in” where needed.
Experience / Qualifications
Bachelor’s degree or higher.
3 to 5 years of proven regulatory experience with class II or III medical devices, and FDA approval for 510k, de Novo for software as a medical device
Experience with new product development standards and documentation for software products.
Nuanced experience in regulatory submissions and technical documentation for medical devices, software and services.
Ability to review and provide critical feedback on design documentation.
Ability to communicate and interact with regulatory agencies and consultants.
Excellent English written and verbal skills.
Strong technical presentation skills.
Strong organisational skills; ability to remain organised and productive in fast-paced work environment with competing priorities.
Work independently, diligently, and efficiently on assigned tasks and projects.
Collaborate seamlessly with teams.
Competitive salary package including share scheme
Free babylon for you and your family
One of the nicest offices you’ll ever see, located in the heart of Chelsea
Free healthy breakfast, and snacks
On site table tennis and video game competitions
Regular social gatherings and an intimate, collaborative environment
A real entrepreneurial spirit and drive to make a tangible difference in the world
Free weekly yoga or football sessions
BUPA health and life insurance
Tagged as: Digital Health, Health, Healthcare