MDR Compliance Operations Specialist

About the role

You 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 Operations Specialist, you'll play a central role in making sure our software as a medical device (SaMD) products meet the highest standards - owning technical documentation, driving change management processes, and ensuring that every update we ship remains compliant, auditable, and grounded in solid clinical and regulatory reasoning. 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, helping ensure that we can move fast without ever compromising on quality or compliance . If you get excited about pairing deep regulatory understanding with real-world engineering, and you want to build systems that clinicians and patients can trust, we'd love to meet you.

Responsibilities

• Assemble and maintain 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 preparation and maintenance 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.
• Support internal audits and contribute to preparations for notified body assessments.
• What you bring
• 1-3 years of experience in regulatory affairs, legal compliance, or MDR compliance operations
• Familiarity 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 products
• 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 important.
• A high work ethic and drive. We are a startup building regulated AI medical software, and this role requires someone who thrives in an intense environment and is willing to go the extra mile.
• Degree in law, biomedical engineering, medicine, or a related field, or equivalent practical experience.
• Fluent in English (spoken and written).
• Bonus points:
• Understanding of change management processes for medical device software.
• Experience with data analysis or research methodology.
• Experience with traceability tools or eQMS platforms.
• Comfortable working with LLM-based tools such as Claude and Codex in your daily workflow.
• Experience with project management and collaboration tools such as Notion or Linear.
• Ability to code or scripting experience.
• Location
• We believe the best ideas happen when we're together. This role is based in our vibrant HQ in the Epicenter building in the heart of Stockholm where you will work primarily from our office to collaborate, connect, and build our culture.
• How to Apply
• We adopt a continuous selection process, so please make sure to apply with your CV in English.
• Our interview process consists of 4 stages:
• Screening interview with Talent Acquisition
• Interview with key stakeholder
• Interview with hiring manager
• Working Day - Join us in the Stockholm office for a half day to experience our our culture firsthand, collaborate with our team, and see how you work in action.

Benefits

Additional Information

Build 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!

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