MDR Regulatory Affairs Specialist

About the role

You care about getting things right - not just in principle, but in practice. You understand that in regulated environments, strong judgment matters just as much as strong documentation. In previous roles, you've likely been the person others turn to when things are unclear, the one who can interpret regulation, make decisions, and ensure that systems, documentation, and products hold up under real scrutiny. At Tandem, you'll take on a central role in shaping how we build and scale compliant AI-powered medical software across Europe. As a Senior MDR Regulatory Affairs Specialist, you'll own and lead key parts of our regulatory work, from maintaining and evolving technical documentation to assessing the impact of product changes and guiding how we navigate MDR in a fast-moving software environment. This is a hands-on role for someone who combines deep regulatory expertise with the ability to operate independently and make calls in complex situations. You'll work closely with compliance, product, and engineering, ensuring that everything we ship is not only innovative and fast - but also robust, defensible, and aligned with the highest regulatory standards.

Responsibilities

• Own and lead the maintenance of MDR technical documentation files for our SaMD products, ensuring continuous compliance.
• Support change management for existing devices. Work closely with the Head of Compliance to assess the regulatory impact of software improvements, determine whether changes are significant under MDR, and ensure the technical file, risk management (ISO 14971), and clinical evaluation are updated.
• Write, review, and maintain clinical evaluation reports and post-market surveillance documentation.
• This is a hands-on role where you actively work on and produce regulatory documentation yourself, alongside guiding and reviewing the work of others.
• Contribute to our regulatory strategy for software as a medical device under EU MDR.
• Bring deep expertise in how software development lifecycles (IEC 62304) map to MDR regulatory requirements.
• Guide members of the compliance team and help build our regulatory processes as we grow.
• Interface with notified bodies and support certification processes as needed.
• What you bring
• Proven, hands-on experience with full-cycle MDR compliance for software as a medical device: from initial classification through to technical file completion and maintenance.
• Strong experience with change management in a regulated SaMD environment. You know how to assess whether a software change triggers a significant change under MDR and what documentation needs to follow.
• Technical understanding of software development processes and lifecycles, particularly IEC 62304 and IEC 62443 where applicable.
• Clinical understanding: experience with clinical evaluations (MEDDEV 2.7/1, MDCG guidance) for SaMD, and ability to critically assess clinical data.
• Deep knowledge of EU MDR, especially Annex II/III technical documentation and GSPR mapping.
• Experience with AI/ML medical device regulations and relevant MDCG guidance is highly valued.
• Fluent in English (spoken and written).
• Bonus points:
• Experience with data analysis or research methodology.
• 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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