Head of Quality and Regulatory Affairs

Machine Medicine Technologies is facilitating the next generation of neurotherapeutics by building software for the intelligent, personalised optimisation of neuromodulation and other precision therapeutics. Our flagship product, Kelvin, is in use at multiple Deep Brain Stimulation (DBS) sites across the globe, enabling the collection of large datasets of unparalleled quality. This data is being utilised to develop a SaMD (Software as Medical Device) tool for automated clinical assessment of Parkinson’s disease.
The FDA awarded our technology Breakthrough Device Designation, recognizing its potential to revolutionize the MedTech industry.
Based in central London (Bermondsey), our company is growing rapidly and we have over £6.5M in funding. We have published papers in numerous high-quality, peer-reviewed journals, including Sensors, Intelligence-Based Medicine, and Nature Parkinson’s Disease. Additionally, we generate 7-figure annual revenues through our commercial activities.
Culture
At Machine Medicine, we are a fast-moving startup with a dynamic team that is passionate about using AI to disrupt the MedTech industry. We encourage our employees to take advantage of career development opportunities that are not typically available at larger, established companies. Our offices are nestled within the vibrant cities of London and Cambridge, designed to encourage face-to-face interaction. We firmly believe the best part of collaboration and synergy happens when the team works under one roof. We value work-life balance and offer a casual dress code. Company Benefits 25 days annual leave (+ Bank Holidays)Unlimited coffee & teaPrivate Medical coverage with Vitality HealthCycle to work schemeElectric car scheme
Application Process
Application: apply with your CV and complete the application form
Online Assessment: a series of 10-minute online tests to assess your relevant skills for the role. The whole assessment should last less than an hour.
Interviews: 2-3 30-minute chats with the team lead and team members on the relevant technical skills and your past experiences
Meet with our CEO: For some roles, you will be invited to meet with Jonathan, our CEO, onsite/online for a 30-minute chat. Quality Department At Machine Medicine TechnologiesHead of Quality and Regulatory Affairs
Quality
Biscuit Factory - London
Full Time
Machine Medicine Technologies is facilitating the next generation of neurotherapeutics by building software for the intelligent, personalised optimisation of neuromodulation and other precision therapeutics. Our flagship product, Kelvin, is in use at multiple deep brain stimulation (DBS) sites across the globe, enabling the collection of large datasets of unparalleled quality. This data is being utilised to develop a SaMD (Software as Medical Device) tool for automated clinical assessment of Parkinson’s disease. The FDA awarded our technology Breakthrough Device Designation, recognizing its potential to revolutionize the MedTech industry.Based in central London (Bermondsey), our company is growing rapidly with 30+ full-time employees and over £6.5M in funding. We have published papers in numerous high-quality, peer-reviewed journals, including Sensors, Intelligence-Based Medicine, and Nature Parkinson’s Disease.25 days annual leave (+ Bank Holidays)Unlimited coffee & tea at the officePrivate Medical coverage with Vitality HealthCycle to work schemeElectric car schemeAbout the role:The Quality team at our company plays a pivotal role in ensuring the excellence of our products and services. The team guarantees that our medical device functions with pinpoint accuracy, high reliability, and utmost safety. Their efforts go beyond our internal operations; they provide the assurance needed to not only meet but consistently exceed the expectations of regulatory bodies, healthcare professionals, patients, and clients.It is an exciting time to join the company as we embark on two ambitious missions: Submitting Kelvin-Parkinson’sDisease technical documentation to FDA for market clearanceAnd support the design and development of new SaMD for other movement disorders, under the Kelvin seriesReporting directly to the CEO, the Head of Quality and Regulatory Affairs will play a vital role as a member of the leadership team, and leading a team of three. If you are a self-starter with an entrepreneurial spirit, passion for the field and perseverance towards a goal, you will fit right in. We are hiring A players that perform the absolute best. This is a superb opportunity for an ambitious Quality professional, with relevant previous experience, to take personal ownership and deliver outstanding results.Key ResponsibilitiesQuality and RegulatoryMaintain the highest degree of product quality and quality systems, grounded by the ability and vision to anticipate and prevent quality and/or regulatory problems.Ensure compliance with ISO 13485 Quality Management System and maintain ISO 27001 certification.Ensure all external audits with Notified Bodies, Regulatory Authorities, and Customers are managed to ensure a positive outcome.Ensure compliance with local and international regulatory compliance in line with relevant legislationOversee the maintenance of product technical documentation (DHF/DMR/DHR)Perform product registrations in relevant jurisdictions, particularly the US and EU.Report vigilance issues and information security incidents to regulatory authorities in terms Leadership and Planning: Grow, motivate and empower the Quality team, through performance reviews and development.Define quality strategy and implement procedures. Set objectives, measure achievement of goals and support the business in achieving its overall strategic goals.Need-to-havesStrong inclination towards and appetite for technology and creative thinking. One of the key aims is to minimise the viscosity a QMS imposes, eliminate unnecessary steps, and automate processes wherever possible. Degree or higher in Sciences (Life or Physical) Knowledge and experience in medical device quality systems and regulatory processes including ISO 13485, ISO 14971, ISO 27001, 21 CFR Part 11, 21 CFR Part 820, MDR 2017/745, IEC 62304.Experience with Software as a Medical Device (SaMD)Proven track record in interactions with Notified Bodies/Regulatory Authorities, especially the FDACertified in Internal/Supplier AuditingProven experience in a relevant position.Nice-to-haves Experience with GDPR and HIPAAQuality certification: ISO 9001Are you interested in the role but do not tick all the boxes? We encourage you to submit your CV. We consider all applications.
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