Lead Auditor - Contractor role

Jobgether

6d • Remote

About The Position

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. You will collaborate with a highly skilled quality team, applying regulatory expertise, providing structured audit documentation, and contributing to consistent, repeatable audit processes. This contractor role is ideal for professionals with strong regulatory judgment, experience in software medical devices, and a dedication to quality and compliance.

Requirements

• 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.
• 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.
• Familiarity with relevant standards, including ISO 14971, IEC 62304, IEC 82304, and cybersecurity considerations.

Nice To Haves

• Experience with software medical devices (SaMD) is strongly preferred.
• Experience with notified bodies or accreditation bodies is a plus.

Responsibilities

• 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.

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.

What This Job Offers

• Career Level: Mid Level