🛠 Tech Stack

💼 About This Role

You'll own technical documentation for AI-powered SaMD products and ensure EU MDR compliance across rapid engineering changes. You'll bridge regulatory rigor with product development, making clinical safety and traceability integral to every software update.

🎯 What You'll Do

• Assemble and maintain MDR technical documentation files (Annex II/III).
• Lead change management to keep technical files compliant after updates.
• Support clinical evaluation documentation and clinical data analysis.
• Collaborate with engineering to capture design outputs and regulatory impact.

📋 Requirements

• 1–3 years in regulatory affairs, legal compliance, or MDR compliance.
• Familiarity with EU MDR technical documentation (Annex II/III).
• Understanding of clinical evaluation processes and clinical data.
• Degree in law, biomedical engineering, medicine, or equivalent experience.

✨ Nice to Have

• Experience with change management for medical device software.
• Experience with traceability tools or eQMS platforms.
• Ability to code or script.

🎁 Benefits & Perks

• 💰 Competitive salary & company stock options
• 🏖️ 25 days/year of paid vacation
• 🧘 5,000 SEK wellness allowance (friskvårdsbidrag)
• 🎉 Social activities: off-sites, after works, parties
• 🌍 Impactful work in AI healthcare with top minds

📨 Hiring Process

Screening call with Talent Acquisition → interview with stakeholder → interview with hiring manager → half-day working session in Stockholm office.

🚩 Heads Up

• Role mixes regulatory, data analysis, and coding expectations for junior level.
• Vague 'competitive salary' and estimated salary may not reflect Stockholm market.