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Quality Assurance & Regulatory Affairs Manager
at Feebris

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  • London
  • fulltime
  • -

About Feebris

With a chronic shortage of clinical professionals and hospital infrastructure, our NHS is struggling more than ever to live up to its promise of universal healthcare. This is particularly challenging for vulnerable communities, such as care homes. At Feebris, we provide health systems with a safer and more accurate way of delivering high quality remote consultations. Our AI-powered platform enables carers to conduct high quality check-ups in their communities, triage health issues proactively, and escalate concerns to clinicians.

Our mission is to prevent hospitalisations and suffering from conditions that could have been prevented or treated at home. We believe that no one should die or suffer from treatable conditions. And yet, every year nearly 1 million children around the world die from pneumonia (a treatable disease). But this is just the tip of the iceberg; the world over (even in the UK), our children and elderly often do not get the care they need until it is too late.

We currently provide our software solution to health and social care providers for elderly people in the UK, and to NGOs that help young children in India. We’ve won awards for our disruptive technology (TechForce19, UKBAA, Children’s Prize), and our founder, Elina, is an internationally renowned speaker on AI in healthcare.

We are a small team; we each are driving to bring innovation to healthcare, growing and performing at our peak, sharing the highs and the lows, and enjoying the company of others that share values and relish being part of something that is bigger than each of us. We are searching for kindred spirits to join our journey. If this is you, then please reach out. You would be joining us at an incredibly exciting time, with the opportunity to shape the company and culture as we grow.

 

The Role & Responsibilities

  • Work closely with Feebris’ founders and expert advisors to progress Feebris’ regulatory work in the UK, focused on CE certification, ISO 27001 and GDPR compliance.
  • Act as a responsible person for regulatory compliance at Feebris, and as a point of contact for regulatory agencies.
  • Maintain and improve our Quality Management System (QMS) to attain ISO 13485 certification.
  • Work with our multi-disciplinary team to establish processes for agile software and machine learning development that comply with the MDR and IEC 62304 standards.
  • Ensure conformity of new products and maintain the Technical File for our CE certified Software Medical Device and ensure post market surveillance obligations are fulfilled.
  • Drive the internal project to secure CE Class II medical device approval under the new MDR.
  • Write and maintain policies and processes and ensure that all employees are trained in and comply with those that apply to them.
  • Review marketing and sales materials to ensure accurate and consistent claims are made that do not breach applicable regulatory requirements.
  • Conduct internal audits to continuously improve Feebris’ QMS and processes.

 

Essential

  • At least 4 years of professional experience in Quality Assurance or Regulatory Affairs for Medical Devices.
  • Experience maintaining a CE marked medical device under the Medical Device Directive (MDD) and advanced knowledge of the new European Medical Devices Regulation (MDR).
  • Experience maintaining and evolving an ISO 13485 compliant QMS.
  • Understanding of agile software development practices and machine learning.
  • Experience in a small team / start-up, and with a proven ability to work independently with little supervision and get things done with a high degree of self-motivation and accountability.
  • Excellent attention to detail, and experience writing policies & processes and running projects.
  • Excellent problem-solving capabilities, introspection, and retrospection.
  • Excellent communication, both written and verbal; ability to simplify complex topics in a way that anyone can understand. 

 

Nice to Have

  • Experience maintaining and evolving processes for design development, verification, and validation for software as a medical device (SaMD).
  • Experience interfacing with auditors in a high-pressure audit situation and during subsequent resolution of non-conformances.
  • Experience marketing a regulated product, with an understanding of product claims/labelling.
  • Mature connections within the medical device competent authority in the UK (MHRA).
  • Experience building a QMS and Technical File from scratch.
  • Experience writing and maintaining Clinical Evaluation Reports.
  • Experience coordinating user studies.
  • Experience with Information Security (ISO 27001) and Data Protection.
  • Experience as an ISO lead auditor.

 

Benefits

  • Impactful work – help take healthcare innovation to market.
  • Real responsibility – make a direct, meaningful impact on Feebris' trajectory.
  • Rockstar team – join our small team, all at the top of their game and driving as one.
  • Massive growth opportunity – potential to grow into leadership quality role.
  • Founder level contribution – work directly with the founders, providing strategic inputs & cross-functional contributions, culture shaping
  • Regular personal development – quarterly 360 performance reviews, fortnightly founder 1:1s, and personal development coaching
  • Competitive Compensation – Salary + Share Options (the most tax friendly way possible for you to own a piece of the company)
  • Output-driven work culture – unlimited paid time off, flexible working hours, remote work

 

If you’re looking for challenging and impactful work on the cutting edge of health tech, then we would love to hear from you!

Interview Process

  1. Phone Interview with Founder (45 mins)
  2. Case study exercise (at home + discussion in final interview)
  3. Face-to-face Final Interviews (2.5 hrs, 1x Skills & 1x Fit)

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