MDR Compliance Associate: SaMD Docs & Audits

The Hub/Danske Bank; Stockholms kommun; On-site; SEK 700,000 - 900,000; Full time

Benefits offered by this job

Stock options

Private medical

Wellness allowance

Parental leave

Pension

Team events

Job summary

Tandem Health is building AI-powered medical software and seeks an MDR Compliance Associate to organize and maintain regulatory documentation. You will ensure Annex II/III files stay accurate, up-to-date, and audit-ready as the product evolves.

You will collaborate with product and engineering, support change management, and help ensure all updates remain MDR compliant while enabling fast, safe delivery to clinicians and patients.

Qualifications

• 1–3 years in regulatory affairs or MDR compliance operations.
• Familiarity with EU MDR requirements, especially Annex II/III.
• Interest in software, AI, and digital health medical devices.

Responsibilities

• Maintain MDR technical documentation files (Annex II/III) for SaMD products.
• Support change management to keep the technical file compliant with MDR.
• Update clinical evaluation documentation and align with MDR guidance.
• Use traceability tools and eQMS to ensure audit-ready records.
• Collaborate with product and engineering to capture design outputs and regulatory impact.
• Coordinate doc updates across teams and support internal audits.

Skills

Regulatory affairs

MDR compliance

Documentation

Change management

Clinical evaluation

Education

Law degree

Biomedical engineering

Medicine

Tools

eQMS

Ketryx

Notion/Linear

Job description

Tandem Health is building AI-powered medical software and seeks an MDR Compliance Associate to organize and maintain regulatory documentation. You will ensure Annex II/III files stay accurate, up-to-date, and audit-ready as the product evolves.

You will collaborate with product and engineering, support change management, and help ensure all updates remain MDR compliant while enabling fast, safe delivery to clinicians and patients.