Senior Medical Device Auditor — SaMD, ISO 13485 & EU MDR

Cure Talent Limited; Stockholms kommun; Remote; SEK 900,000 - 1,100,000; Full time

Job summary

Cure Talent Limited is partnering with a growing medical device certification organisation specialising in SaMD and AI-enabled medical technologies. We seek an experienced Medical Device Auditor to conduct Stage 1 and Stage 2 ISO 13485 and EU MDR audits from a Sweden-based, remote setup with travel to Stockholm and client sites as needed.

The ideal candidate has hands-on SaMD experience, strong ISO 13485 knowledge and a track record auditing in regulated environments.

Qualifications

• Hands-on SaMD experience and regulatory understanding.
• Practical knowledge of ISO 13485 quality management systems.
• Familiarity with EU MDR and related software standards.

Responsibilities

• Conduct Stage 1 and Stage 2 ISO 13485 and EU MDR audits.
• Plan, lead and document audit activities with evidence trails.
• Produce robust audit reports and communicate findings clearly.
• Assess nonconformities with objective evidence.
• Collaborate with Quality, Regulatory, Software Engineering and leadership.
• Manage audit timelines from preparation to follow-up.

Skills

SaMD experience

ISO 13485 knowledge

MDR / EU regulatory knowledge

Auditing experience

Strong communication

Education

Science/Engineering degree

Job description

Cure Talent Limited is partnering with a growing medical device certification organisation specialising in SaMD and AI-enabled medical technologies. We seek an experienced Medical Device Auditor to conduct Stage 1 and Stage 2 ISO 13485 and EU MDR audits from a Sweden-based, remote setup with travel to Stockholm and client sites as needed.

The ideal candidate has hands-on SaMD experience, strong ISO 13485 knowledge and a track record auditing in regulated environments.