Manager, Quality and Regulatory Assurance (PRRC)

Take ownership of quality and regulatory compliance and help bring life-changing Parkinson’s care technology safely to patients across Europe. We are looking for a hands-on Manager, Quality and Regulatory Assurance to lead our QMS and act as our PRRC as we scale. About Adamant Health Adamant Health is a health-tech AI company entering a scale-up phase on a mission to revolutionise the care of Parkinson’s disease through data-driven disease management, enabling earlier detection of motor symptoms and contributing to better patient outcomes. Founded in 2020 as a university spin-off, our CE-marked data-analysis technology delivers detailed, accurate symptom data that supports continuously optimised, personalised treatment. Our customers are public and private healthcare providers, and we aim to achieve rapid growth in the years ahead. The role This is a pivotal role at the heart of our compliance and product integrity as a Manager, Quality and Regulatory Assurance , you will own and continuously improve our Quality Management System, act as our Person Responsible for Regulatory Compliance (PRRC), and be the primary point of contact for Notified Bodies and regulatory authorities. You will lead our regulatory strategy end-to-end – from technical documentation to product registrations and lifecycle compliance – while building practical and scalable quality processes that support innovation rather than slow it down. In addition, you will lead projects with a strong regulatory dimension, including clinical trials. What you will do Own, maintain and continuously improve our Quality Management System in compliance with the EU MDR, US FDA requirements, and other applicable regional regulations. Act as our Person Responsible for Regulatory Compliance (PRRC) and serve as the primary contact for Notified Bodies and regulatory authorities. Lead regulatory activities, including regulatory strategy, technical documentation, product registrations, regulatory submissions and compliance throughout the product lifecycle. Plan and conduct internal audits, coordinate external audits and inspections, and drive CAPA and continuous improvement activities. Develop practical, scalable quality processes that support innovation and efficient product development in a fast-paced start-up environment. Provide hands-on quality and regulatory guidance to cross-functional teams, deliver training, and translate regulatory requirements into practical ways of working. Monitor changes in applicable regulations and standards, assess their business impact, and drive implementation across the organisation. Lead and manage projects, including clinical trials. What we are looking for A Master’s degree (or higher) in engineering, life sciences, software engineering, biomedical engineering, or another relevant discipline. At least five years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry. Strong working knowledge of MDR (EU) 2017/745, ISO 13485, IEC 62304, ISO 14971, and FDA requirements and processes. Experience acting as a QMS owner, PRRC, or in a similar Quality & Regulatory leadership role. Experience preparing technical documentation and leading Notified Body and/or regulatory authority audits and inspections. A strong understanding of, and experience with, Software as a Medical Device (SaMD) and modern software development practices, as well as a good understanding of hardware medical device regulation and practices. A demonstrated ability to build, prioritise and execute Quality & Regulatory activities independently in a start-up environment. A pragmatic and hands-on mindset, with the ability to combine strategic thinking with operational execution and an eye on business needs. Excellent communication, collaboration and stakeholder management skills, with fluency in English; Finnish is considered an advantage. Who you are Self-motivated and confident to voice your own views and challenge the status quo when it matters. Well-networked, with strong collaborative and interpersonal skills. Able to plan and manage your own work independently. Hands-on and energised by getting into the detail without losing the big picture. What we offer A meaningful role with direct impact on patient lives and the future of Parkinson’s care. A competitive salary, complemented by employee stock options – in line with common start-up practice. A diverse, expert team and a high-ambition, dynamic start-up culture. Freedom to organise and arrange your own work. The chance to shape the quality and regulatory foundations of an internationally scaling health-tech business from an early stage. How to apply Send your application and CV via LinkedIn by 21 August 2026 at the latest. Please include your salary expectations and earliest possible start date. We review applications on a rolling basis and start interviews as soon as we receive qualified candidates – so don’t wait to apply. Are you ready to help us change the way Parkinson’s disease is treated? We would love to hear from you.