Medical Device Auditor, Stockholm

Medical Device Auditor in Stockholm

The Opportunity

PharmaRelations is recruiting a Medical Device Auditor, on behalf of an innovative and fast-growing organization operating at the intersection of medical technology, regulatory compliance, and advanced digital solutions.

The company helps medical device manufacturers bring safe and innovative products to market by combining regulatory expertise, technical knowledge, and modern technology. Working with leading MedTech companies, the organization is committed to improving certification efficiency while maintaining the highest standards of quality and patient safety.

This is an exciting opportunity for an experienced Medical Device Auditor with a passion for quality, compliance, and enabling innovative healthcare technologies to reach patients efficiently.

Location: Stockholm, Sweden (Remote).
Employment Type: Full-time

The Role

As a Medical Device Auditor, you will conduct audits of medical device manufacturers' quality management systems and support certification activities. You will assess compliance with applicable standards and regulations, review evidence, interview stakeholders, and provide clear audit conclusions.

The role combines document review, process assessment, technical discussions, and stakeholder engagement. Limited travel is required.

Key Responsibilities

• Conduct QMS audits against ISO 13485, EU MDR, and UK MDR requirements.
• Assess documentation, records, and processes for regulatory compliance.
• Interview stakeholders and evaluate operational effectiveness.
• Prepare accurate and timely audit reports.
• Communicate findings professionally and constructively.
• Review corrective actions and supporting evidence.
• Support high standards of quality, safety, and compliance.

Required Qualifications

• Degree in a scientific discipline in engineering, medical, or related.
• Minimum 4 years' experience within the medical device industry.
• Minimum 2 years' experience auditing or managing an ISO 13485 Quality Management System.
• Working knowledge of EU MDR and/or UK MDR requirements.
• Strong written and verbal communication skills.
• Experience with software-based medical devices or software development environments, including software lifecycle, validation, and testing processes.

Preferred Qualifications

• Experience conducting audits for a Certification Body or Notified Body.
• Experience with medical device software and digital health technologies.
• Experience working in highly regulated environments.

Who We Are Looking For

You are analytical, detail-oriented, and comfortable engaging with diverse stakeholders. You enjoy assessing complex processes, identifying improvements, and supporting organizations in maintaining high standards of quality and compliance.

You thrive in a fast-paced environment, have an additive mindset, and enjoy solving challenges for clients. Strong communication skills combined with technical expertise enable you to contribute to safer healthcare solutions for patients worldwide.

Next step in process

If interested, please upload your application and CV using the apply button.

Applications will be reviewed on an ongoing basis until the right candidate has been found.

For questions regarding the position, please contact: Helle Neel : Helle.jensen@pharmarelations.dk