Lead Auditor - Contractor role

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Lead Auditor - Contractor role in the United States.

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.

• 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.

• 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.

• 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.

Why Apply Through Jobgether?

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

 Why Apply Through Jobgether? 

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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