Project Manager for Medical Devices and Regulatory and Quality

  • Babylon Health
  • First Floor, 60 Sloane Ave, Chelsea, London SW3 3DD, UK
  • Dec 02, 2019

Job Description

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…

Purpose of RoleThe MDRQ Project Manager manages regulatory and quality projects, related to key regulatory events (e.g. passing an audit), regulatory strategy, technical file updates or the meeting of new or improved quality or regulatory requirements. As these activities are all cross-functional with many stakeholders, the MDRQ Project Manager needs to communicate objectives, track progress and chase project participants. The role requires the creation of project and team newsletters, status reports and project related material as required.   

Key Responsibilities:

Prepare for and run Steering Committee meetings and associated key decisionsCommunicate with project stakeholders to align objectives, approach and progressCreate focus groups to assess particular blockers or project itemsMaintain project plan and check progress across multiple engineering, product, safety and delivery teams Communicate tasks to stakeholders and chase as required Communicate and educate a wider audience on project, objectives and benefitsTake meeting minutes or summarise meetings and actionsWork with all stakeholders to address issues and find solutions Run project workshops as requiredMaintain MDRQ or project related status reports Write monthly newsletter

Key Skills Required

 Communicator - Adept at using a wide array of methods in order to allow a message to reach a varied audience. Simple summaries, visually represent situations to get to the root of the problem, on a variety of communication channels such as slack, email, presentations, confluence, newsletters etc Negotiator - Ability to get to the root of a problem to understand what is driving people or making them resist. You’ll have a flair for finding out the facts and talking to people’s pain points with openness and trustFacilitator - Getting the right stakeholders together in order to facilitate the brainstorming/problem solving process, supporting an informed decision-making processCreating Content - Writing up conversations and re-playing them in a succinct way, summarising situations and opinions, visually representing lifecycles, problems, and solutions, creating newsletters and training materialTranslator/Interpreter - Making sure everyone understands what finished looks like, how we get there, and ensuring people are aligned on scope and terminology, simplifying technical language and educate disparate teams on the regulatory space, it’s dependencies and why we are doing things

Person Specification

Flexible, driven, passionate, organised starter-finisher, happy to chase and follow up on small and large activities, project manage and communicate with a wide group of stakeholders of all levels

Qualifications and Experience

Essential:          At least 5 years of experience in project managementStrong record of full project lifecycle and finishing projects on timeExperience and interest in regulated, accredited or compliance environmentsDegree related to project management or regulatory affairs
Desirable:         Experience in medical device or related industryExperience in (stand alone) software project managementExperience in Agile Software development