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Role Description

This role offers an exciting opportunity to independently conduct high-quality audits of medical device Quality Management Systems, ensuring compliance with ISO 13485, EU MDR, and UK MDR standards. You will work with cutting-edge medical AI and healthtech products, helping innovative technologies reach patients safely and efficiently. The position is fully remote and flexible, allowing you to contribute as a trusted auditor while maintaining autonomy in your schedule.

• Conduct remote audits of medical device manufacturers’ Quality Management Systems under ISO 13485, EU MDR, and UK MDR.
• Provide clear, structured audit documentation and evidence-based conclusions.
• Ensure audits are delivered consistently and meet high-quality standards aligned with the organization’s methodology and values.
• Apply regulatory expertise to assess compliance of software and hardware medical devices, including SaMD.
• Maintain engagement with audit teams and stakeholders, providing constructive communication and guidance throughout the audit process.
• Contribute to audit planning, preparation, and follow-up activities, ensuring alignment with notified body or certification standards.

Qualifications

• Bachelor’s degree in software engineering, computer science, physics, biology, chemistry, engineering, human physiology, medicine, or pharmacy.
• Minimum 4 years of experience in the medical device industry.
• At least 2 years auditing or managing QMSs under ISO 13485, EU MDR, and/or UK MDR.
• Authorization or qualification to act as a Lead Auditor in a Certification or Notified Body is required.
• Experience with software medical devices (SaMD) is strongly preferred.
• Familiarity with relevant standards, including ISO 14971, IEC 62304, IEC 82304, and cybersecurity considerations.
• Strong regulatory judgment and ability to interpret and apply regulatory requirements independently.
• Excellent communication skills, consistency in audit quality, and ability to work with minimal supervision.
• Experience with notified bodies or accreditation bodies is a plus.

Benefits

• Fully remote, flexible contractor role.
• Autonomy in scheduling based on audit demand and availability.
• Opportunity to work with innovative medical AI and healthtech products.
• Engagement with a highly skilled quality and regulatory team.
• Exposure to cutting-edge medical device regulatory processes and standards.

Company Description