MDR Compliance Associate (AI)

Location: Stockholm, Sweden; on-site at the Stockholm HQ

Company

hirify.global is a fast-scaling health-tech startup building AI-powered medical software designed by clinicians for clinical workflows and patient care.

What you will do

• Maintain MDR technical documentation files under Annex II and Annex III for software as a medical device products.
• Assess software updates and improvements through the change management process, updating technical files to remain compliant.
• Maintain clinical evaluation documentation and support clinical data analysis in line with MDR, MEDDEV, and MDCG guidance.
• Use Ketryx and the in-house eQMS to keep documentation traceable, version-controlled, accurate, and audit-ready.
• Collaborate with product and engineering teams to capture development outputs and assess the regulatory impact of software changes.
• Support internal audits and preparations for notified body assessments.

Requirements

• 1–3 years of experience in regulatory affairs, legal compliance, or MDR compliance operations.
• Familiarity with EU MDR technical documentation requirements, especially Annex II and Annex III.
• Understanding of clinical evaluation processes, clinical data, and the role of clinical evidence in MDR compliance.
• Degree in law, biomedical engineering, medicine, or a related field, or equivalent practical experience.
• Structured, detail-oriented, hands-on approach with strong ownership and attention to accuracy.
• Fluent English, spoken and written, is required.

Nice to have

• Understanding of change management for medical device software.
• Experience with data analysis or research methodology.
• Experience with traceability tools or eQMS platforms.
• Comfort using LLM-based tools such as Claude and Codex.
• Project management tools experience, including Notion or Linear, or coding and scripting experience.

Culture & Benefits

• Work primarily from the Stockholm office with close collaboration across product, engineering, and clinical teams.
• 30 days of paid vacation per year.
• 5,000 SEK wellness allowance plus an additional 6,000 SEK yearly for other health-related initiatives.
• Company stock options, private medical insurance, pension program, and parental leave top-up.
• Mental health support through Mindler and social activities including off-sites and team events.
• Background check required before hiring due to access to sensitive patient data.

Hiring process

• Screening interview with Talent Acquisition.
• Interviews with a key stakeholder and the hiring manager.
• Half-day Working Day at the Stockholm office.