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…
What are we looking for?
Regulatory Affairs Manager (Medical Devices)
Support the Regulatory Lead in the creation and running of the Regulatory Affairs team
Advise on regulatory strategy for new products or product features
Manage, plan and submit regulatory submission documentation in different countries and with partners
Work closely with Regulatory Authorities for submissions, listings, incident reporting etc.
Monitor regulatory developments and provide regulatory intelligence for Software as a Medical Device (SaMD)
Support the build-up of a regulatory affiliates organisation
Requirements for the ideal candidate:
Understanding of EU and US regulatory requirements, current and future (e.g. MDR)
Ideally, detailed regulatory expertise in one other region, e.g. Asia
Regulatory submission experience
Experience with stand-alone healthcare software / Software as a Medical Device (SaMD)
Understanding of Agile development and the Software Development Life Cycle
Willingness to work across teams and in related areas, e.g. Quality, Safety and Compliance
Experience of start-up/ high-growth environment
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
Free weekly yoga or football sessions
BUPA health and life insurance
Tagged as: Digital Health, Health, Healthcare
We are a team on a mission, to put accessible and affordable healthcare in the hands of every person on...Apply For This Job