As the Senior US Regulatory Manager, Medical Devices, you will manage the medical device regulatory strategy for Babylon US and Canada, including laying the foundations for local Quality Management Systems, local documentation, and future FDA interactions. 

WHAT YOU’LL WORK ON

• Drive regulatory strategy for US and Canadian markets, assuring early consideration of regulatory engagements with the FDA and other stakeholders
• Support the product development team by providing regulatory assessments of proposed product changes and new features for the US and Canada
• Review US and Canadian marketing material and claims
• Assess US and Canadian user complaints and product feedback
• Support the US teams in the preparation and maintenance of product and design documentation
• Establish a local Quality Management System, as required
• Support Commercial teams by providing regulatory input to proposed US deals, contracts, and the product pipeline
• Support internal and external audits by customers and regulators, if and when required
• Stay abreast of current and novel regulatory developments in the US and Canada
• As part of a new start-up with a highly collaborative culture, perform other related regulatory and quality duties and “pitch-in” where needed

WHAT WE’RE LOOKING FOR

• Ability to analyze complex regulatory frameworks and design submission strategies, allowing Babylon to clear all regulatory hurdles and go to market in time
• Nuanced experience in regulatory submissions and technical documentation for medical devices, software, and services, including De Novo and 510(k) pathways
• Knowledge of CFR 820 and related quality processes.
• Ability to review and provide critical feedback on design documentation
• Ability to communicate and interact with regulatory authorities and consultants
• Ability to communicate and manage multiple internal stakeholders, including senior stakeholders 
• Excellent English written and verbal skills
• Strong technical presentation skills
• Strong organizational skills; ability to remain organized and productive in a fast-paced work environment with competing priorities
• Work independently, diligently, and efficiently on assigned tasks and projects. Proactively drive tasks
• Collaborate seamlessly with colleagues and teams

WHO YOU ARE

• Bachelor’s degree or higher (in medical device related field desirable)
• At least five years of experience in the US medical device industry
• At least three years of experience working in a regulatory department 
• Proven regulatory experience with US medical devices, including 510(k) and De Novo pathways for software as a medical device
• Audit experience (FDA or MDSAP) 
• Experience with Canadian medical device regulations
• Experience in Software development, ideally with stand-alone medical device software applications

WHAT WE OFFER

• Competitive salary
• New Hire Company Stock Grants (RSU)
• Refresh Company Stock Grants (RSU)
• Unlimited PTO
• Excellent Medical, dental and vision plans
• Access to flexible spending account and health savings account 
• Competitive retirement plan
• Flexible working hours/remote working options
• Weekly remote yoga sessions

WORKING AT BABYLON 

Whether you work in one of our amazing offices or a distributed team, Babylon is highly collaborative and fun! You’ll have a chance to work in a fast-paced environment with experienced industry leaders. We have a learning environment where you can make an impact.

WHO WE ARE

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.

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…

DIVERSITY AT BABYLON

We believe that difference inspires a better, healthier world. That’s why it’s at the heart of everything we do. From our people to our products, difference enriches every part of our business and creates a culture based on equality of opportunity, and in which all Babylonians can progress their careers. We’re committed to creating an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, colour, religion, sex, pregnancy status, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, and any other characteristic protected by applicable law.