QA/RA Specialist

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

About The Role
We are looking for a QA/RA Specialist to join our Compliance Team and support the implementation and maintenance of our Integrated Management System (QMS + ISMS). This role is ideal for someone with experience in medical device software quality who enjoys working on processes, documentation, and compliance activities, helping build a robust quality culture in a fast-moving environment.

At Tandem, those experiences will be used to make sure our technology meets the highest possible bar for safety, reliability, and compliance, so clinicians can trust every interaction. You'll help us strengthen our quality foundation as we move fast, scaling a system that's transforming how healthcare works.

You'll work closely with the Compliance Lead and other team members to ensure that our management systems meet regulatory requirements such as ISO 13485, MDR, ISO 27001, and other standards. While the role focuses on non-technical QA procedures, you should be comfortable understanding the software development and testing context and have a genuine interest in software development and AI, so you can collaborate effectively with engineering teams and ensure compliance of product-related activities.

This is a high-impact role where you'll shape how quality, speed, and innovation coexist. You'll make sure our systems and processes evolve alongside our products, helping Tandem stay both compliant and cutting-edge.

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.

*What you will do*

• Maintain and update QMS and ISMS documentation (e.g. SOPs, templates, records) and oversee quality records such as training logs and CAPA logs.
• Support the implementation of regulatory requirements across the organisation, including integration into daily processes through collaboration with engineering, security, operations and legal teams.
• Assist with internal audits and support preparation for external audits and inspections.
• Support supplier qualification and ongoing supplier management activities.
• Ensure ongoing software development and release activities meet regulatory requirements (e.g., documentation completeness, traceability, validation evidence).
• Support risk management activities and continuous improvement of the QMS.
• Prepare and maintain the technical file for medical devices, ensuring ongoing regulatory compliance.

*What you bring
Required:*

• 2–4 years of experience in Quality Assurance in the medical device software or related regulated industry.
• Solid understanding of ISO 13485, MDR, ISO 27001 and related quality/regulatory frameworks.
• Familiarity with software development life cycle management (IEC and software testing.
• Excellent organisational and documentation skills.
• Fluent in English (spoken and written).

Bonus points:

• Experience with FDA 21 CFR 820, MDSAP, DCB0129.
• Experience in start-up or fast-paced environments.
• Experience using Notion, Linear or specific software tools for software lifecycle management.

What We Offer

• A key role in ensuring quality and compliance in a growing medical software company.
• Close collaboration with a passionate and multidisciplinary team.
• The opportunity to shape and improve quality processes.
• A supportive environment for professional development in regulatory and quality domains.

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 hiring manager
• Interview with key stakeholder
• 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

• Competitive salary & company stock options
• 25 days/year of paid vacation
• 5,000 SEK wellness allowance (friskvårdsbidrag)
• Social and team-building activities (off-sites, after works, winter/summer parties)
• An opportunity to make a real positive impact in the world of healthcare
• Work with some of the best minds in AI, healthcare, and engineering.

We review our benefits packages on a regular basis and might modify our benefits from time to time.
Culture at Tandem
At Tandem, we move fast, think big, and take ownership. We're a high-performing, diverse team with a shared drive to change the future of healthcare - and we're just getting started.

Our culture is built on action, ambition, and learning. You'll be trusted to take the lead, challenge yourself, and make an impact from day one. We believe real growth happens when you're stretched, supported, and surrounded by smart, passionate teammates who want to win together.

Even though we're spread across countries, we come together often in Sweden for team meetings, social events, and offsites - blending global reach with real human connection.

We hire for talent, potential, and attitude - valuing different backgrounds and fresh perspectives. Great ideas come from everywhere, and we're building a team that reflects the world we want to change.