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    Junior Regulatory Affairs Specialist - London, United Kingdom - Limbic

    Limbic
    Limbic London, United Kingdom

    1 week ago

    Default job background
    Full time
    Description

    Limbic is making mental healthcare available to everyone, everywhere.

    Limbic's vision is to ensure the highest quality therapy is accessible to everyone, everywhere. The way we do that is by deploying AI responsibly, using it to augment clinical care and reduce barriers to accessing therapy at scale. Limbic is already used in over 30% of Talking Therapies in the NHS and is deemed safe and effective after successfully gaining UKCA Class IIa certification, the only AI mental health decision support tool to do so.

    As a Junior Regulatory Affairs Specialist, you'll be joining a growing Compliance and Regulatory department operating at the forefront of AI, software and medical devices in mental health. You will take ownership of Limbic's quality management system and will work cross departmentally to ensure Limbic retains its position as the most accredited and trusted mental health technology on the market.

    What you'll be doing at Limbic:

    • Managing Limbic's quality management system, from the day-to-day procedures to auditing, training and monitoring
    • Iterating on and improving our QMS processes as the company scales
    • Supporting on medical device certifications, audits, file updates and core SaMD process development to continue Limbic's precedent as a highly accredited mental health AI company
    • Serving as our compliance champion working closely with our mental health services and cross-functionally with research, AI, product and growth internal teams to embed our compliance principles at the heart of everything we do
    • Keeping up to date with relevant legislation, methodologies, standards and appropriate regulatory frameworks to keep Limbic at the cutting edge of AI, software, medical devices and mental health

    Job Details:

    • Salary = £35,000 + stock options
    • Limbic is a remote-first company, but alignment with core UK hours is required
    • Reporting into US General Manager

    Requirements

    Who you are:

    • Detail oriented with experience in compliance processes of auditing, reviews and continuous improvement
    • First hand experience of ISO 13485 and UK MDR, preferably in the context of software devices and healthcare
    • Highly organised, able to create clear project plans, juggle priorities and drive work forward cross-functionally
    • Self-starter with a strong sense of ownership, adaptability, and a willingness to take on new challenges
    • Comfortable with uncertainty and the unknown
    • Your default is to use data to problem solve and craft scalable compliance systems

    Benefits

    • Flexibility regarding fully remote, from our central London office or hybrid
    • Twice a year company wide meet-ups in Europe
    • 25 days PTO
    • Paid maternity, paternity, parental leave packages
    • Equity share options

    We take employee wellbeing seriously at Limbic and in addition to the above we offer:

    • Quarterly 'life' days
    • Access to mental health support

    About Limbic:

    Limbic is making mental healthcare available to everyone, everywhere. We're growing quickly and we're backed by top-tier investors, as well as Innovate UK, Digital Health London, Entrepreneur First, and the European Commission.

    It's challenging. We're ambitious. And we're supporting one another to achieve our best and make real impact in the world.

    Find out what Limbican's think about the working culture here.

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