MDR Compliance Associate

MDR Compliance Associate LocationStockholmEmployment TypeFull timeLocation TypeOn-siteDepartmentProduct & EngineeringBuild something monumental for Healthcare!At Tandem Health we’re reimagining healthcare by putting clinicians first. Our platform - designed by clinicians, for clinicians - is built on deep insight into real-world pain points, with intuitive medical notes and workflows that truly support patient care.We’re a fast-scaling health-tech company backed by top investors and expanding globally. We move fast, stay curious, and believe building something that matters starts with an extraordinary team. If you're passionate about impact and innovation, we'd love to meet you!About the RoleYou care about things being done properly. Not just documented, but correct, traceable, and defensible. In previous roles, you were likely the person who made sure nothing slipped through the cracks - the one who understood that in regulated environments, details matter because they compound into trust.At Tandem, you’ll bring that mindset to the forefront of one of the most important challenges in modern healthcare: building AI-powered medical software that is not only fast-moving and innovative, but fully compliant with European regulation. As an MDR Compliance Associate, you’ll play a central role in maintaining and organizing the technical documentation behind our software as a medical device (SaMD) products, ensuring documentation stays accurate, up to date, and audit-ready as our products evolve. You'll support change management activities, collaborate closely with product and engineering teams, and help ensure that every update we ship remains compliant with MDR requirements. This is a hands-on role for someone who thrives on structure, takes real ownership, and wants to work close to both product and engineering, making sure our documentation reflects the reality of the product while enabling the team to move fast without compromising quality or compliance.If you get excited about bringing order to complex documentation, working closely with technical teams, and helping build systems that clinicians and patients can trust, we’d love to meet you.What you will doSupport on the day-to-day maintenance of MDR technical documentation files (Annex II/III) for our software as a medical device (SaMD) products.Play a key role in our change management process. When software is updated or improved, ensure the technical file is assessed, updated, and remains compliant with MDR requirements.Support the maintenance and updating of clinical evaluation documentation, including clinical data analysis, ensuring alignment with MDR requirements and MEDDEV/MDCG guidance.Work within our traceability tools (Ketryx) and in-house eQMS to keep documentation audit-ready, version-controlled, and up to date.Collaborate with engineering and product teams to capture design and development outputs and assess the regulatory impact of software changes.Coordinate documentation updates across teams to ensure our technical files accurately reflect product changes.Support internal audits and contribute to preparations for notified body assessments.What you bring1–3 years of experience in regulatory affairs, legal compliance, or MDR compliance operationsFamiliarity with EU MDR requirements, particularly technical documentation (Annex II/III)A genuine interest in software, AI, and how medical device regulations apply to digital health productsEnjoy working with structured documentation and have a strong eye for detail. You're the type of person who likes keeping things organized, accurate, and easy to follow.Structured, detail-oriented, and willing to take real ownership of your work. This is a hands-on role in a fast-moving team where the pace is high and the work matters.Understanding of clinical evaluation processes and clinical data. You will work closely with clinical documentation, so a baseline grasp of clinical evidence and its role in MDR compliance is...