Employment Type
Permanent
Job Location
London
Date posted
May 24, 2019

Position: Head of User Safety and Compliance, London

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Head of User Safety and Compliance, London

Quin is a female-found healthtech startup challenging the conventional wisdom about insulin-treated diabetes. You’re an amazing human who would love to be the lynchpin of our regulatory world.

In this newly created role, you’ll connect our team to the value of quality and safety and set the direction for how we approach regulatory compliance. As a startup that is used to pushing boundaries, we’re open to a different take on the traditional regulatory role and we feel it would suit either;

  • An experienced QA/RA specialist with exposure to SaMD looking for a hands-on role that’s fundamentally different to all the other regulatory affairs and compliance jobs out there

or

  • A Quality Assurance/Product Manager/Software Engineer from an agile software delivery background looking to move into healthtech/SaMD. In return for your agile experience, we will happily provide the education and training to fill any gaps in regulatory knowledge
Our ideal human can
  • Contribute to discussion about a wide array of complex engineering, design, and technical/logistical issues
  • Make the serious business of user safety an engaging topic that the rest of Quin embraces enthusiastically. You do this through empathy, passion and connection not quoting from the regulatory rule book
  • Deconstruct complex issues and make the abstract concrete. You have an unerring ability to distil things to the simplest that they need to be
  • Influence at all levels and achieve goals without direct control
  • Collaborate with the team and create an environment where regulatory enables innovation and contributes to customer value
  • Thrive in an empowered, transparent, and sometimes imperfect startup environment

We use machine learning to make a mobile medical app that helps people with insulin-treated diabetes make self-care decisions and unlock more personalised treatments. Our app takes data from existing diabetes devices, wearable sensors and user inputs to observe and codify each individual’s unique insulin intervention approach. As it learns, it gives them more personalised guidance in the moment they need it.

Reporting to our CEO and working with our 12-person team, you will get to

Embed quality and safety in our agile processes

  • Incorporate user-centred risk analysis and ongoing risk control into all processes from nascent idea to release, including surveillance of use by our customers
  • Participate daily in the creation, validation and analysis of requirements, user stories and design from a quality and compliance perspective
  • Empower an evidence-based approach to compliance and make sure the right evidence is collected
  • Keep our Quality Management System and documentation up to date and make sure the entire company is working within its parameters
  • Validate, support and sign off monthly software releases for our medical device and own the creation of the Technical File for each release
  • Participate in testing our product throughout each cycle, together with everyone else in our team

Change hearts and minds

  • Translate the true purpose of regulatory so everyone sees it as core to value creation for our customers, not a straightjacket
  • Work with our founders to incorporate on-going regulatory needs into our business strategy and planning
  • Bring a user-centred regulatory mindset into every aspect of our operations: “here’s the evidence this helps our users” NOT “we can’t do that because of regulatory”
  • Enable the user-centred regulatory mindset throughout training and onboarding

Drive continuous improvement of regulatory matters

  • Define our regulatory strategy for new products and product features
  • Expand our existing CE Marked class I medical device to class IIa compliance under the new MDR regulations, and eventually class IIb
  • Expand our Quality Management System to full ISO 13485 compliance
  • Manage, plan and submit regulatory documentation, listings and incident reporting with our partners and Notified Body
  • Initiate our process with the FDA and other regulatory systems worldwide
  • Work with Notified Bodies and external partners on audits
  • Solve what an agile approach to documentation looks like in a highly regulated environment
Contact

Quin challenges the conventional thinking and received wisdom of the medical and pharmaceutical worlds. We work with a massively diverse set of user needs, turning human experience into science. The majority of people in our company are from groups that are historically under-represented in tech, and everyone believes the more inclusive we are, the better our product will be. To do that, we’ve created an environment where everyone can bring their whole selves to work, and we welcome applications from all.

If you’d like to find out more please contact suzi@quintech.io