Quality & Regulatory Affairs Manager

At Bitfount our goal is to make the world’s intractable data interactable. The limitations of current data infrastructure have created painful, slow, expensive and often ineffective workarounds for what should be seamless collaborations between trusted partners. So we’re building a missing piece of global infrastructure: a secure network to enable organisations to send algorithms to data. This means they can share the benefits of their data with each other, without having to go through the painful and risky process of moving it around, without compromising its privacy, and without even needing to expose any raw data. Right now, we’re heads-down on applying our platform to the problem of clinical trial recruitment. We’re enabling privacy-preserving collaboration between healthcare providers, pharmaceutical companies and AI algorithm developers, which removes a major friction point in the process and helps ensure critical medicines make it through trials and into the hands of those who need them much sooner. Learn more about how we work at bitfount.com/company/careers More about you Bitfount is seeking an experienced Quality and Regulatory Affairs Manager to build and oversee our Quality Management System and lead our regulatory function. Our unique offering is at the intersection of cutting-edge AI, ML, analytics, privacy and security, and healthcare. This role will be pivotal in ensuring compliance with relevant regulations in the medical sector and helping us shape the future direction of our product. Your work will include Leading the compliance efforts against ISO13485, ISO27001, SOC/2, HIPAA, GDPR (and other info sec). Actively working with the product and engineering teams to identify Quality Management System (QMS) processes and Regulatory requirements Building processes to enable regular updates to our machine learning focused platform, while remaining compliant with relevant regulations Manage internal and external audits to ensure compliance with regulatory requirements Help build out our network of sites by collaborating with relevant teams to complete onboarding questionnaires, RFIs & due diligence. Act as the in-house quality expert, advising and supporting internal and external stakeholders Collaborate with cross-functional teams to ensure regulatory and quality compliance throughout the product lifecycle Facilitate design reviews for product iterations and uphold the integrity of associated technical documentation. Enhance continuous integration practices encompassing development, testing, and release phases. Develop regulatory strategies in alignment with business priorities and update strategy in line with regulatory changes. ️What we offer Compensation package Salary based on experience and market rate Share options Flexible work and tools Hybrid Working policy – 1 day in our lovely Shoreditch office – Fora Montacute Yards A personal budget for any equipment you need to do your job Holidays and family time 25 days holiday a year, plus bank holidays – please use them all! Enhanced paid maternity, paternity and adoption leave Learning and development Personal learning budget to use on books, courses, conferences and more Health & Wellbeing Private Medical Insurance including optical, dental and mental health. Cycle to work scheme Community Regular (optional) team and company events in and out of the office Lunch on Bitfount once a week in the office Bitfount is an equal opportunity employer. We do not discriminate on the basis of ethnicity, religion, sexual orientation, gender identity, family or parental status, national origin, veteran, neurodiversity status or disability status. Please note: all successful applicants will be subject to a DBS reference check in line with industry norms. You may be fit for this role if you Minimum of 3 years of experience in the management of QMS within the medical device industry Extensive knowledge of quality management systems, and especially ISO 13485 requirements (even better if you have been IRCA-certified or similar as an ISO 13485 Internal Auditor) Experience with medical device software and ISO 27001 is desirable Pharmaceutical industry experience High attention to detail and accuracy. Strong communication skills to bridge the gap between design, product, engineering and compliance functions Interest in the compliance challenges in a machine learning context, as well as interest in new privacy-preserving technologies Flexibility and adaptability to work in a fast-paced, dynamic environment with changing market conditions. Highly curious; not satisfied with getting something to work, you want to understand why it works and how to improve the quality of the product/software The interview process: Getting to know you: 30 minute chat with our People and Operations manager to talk about your experience and the role. Technical Screen: 60 minute discussion of how you’d tackle compliance in a company like Bitfount Leadership interview: 60 minute chat with our CEO about your prior accomplishments and the challenges you’ve faced in compliance. Offer call #J-18808-Ljbffr