Gcp Auditor

Summary

Join RQM+, a leading MedTech service provider, as a contract-based Auditor supporting our Global Audit Practice. You will manage projects, plan and execute audits, and issue reports for clients in the U.S., conducting both on-site and remote audits. A significant portion of your role involves mentoring junior auditors and contributing to training module development. You will also identify opportunities for additional client support and maintain your expertise in evolving regulations. This client-facing role requires strong communication, problem-solving, and interpersonal skills. RQM+ offers a competitive compensation package and a focus on work-life balance.

Requirements

• Be a professional and qualified Medical Device lead auditor, with 10+ years of experience in the Clinical Research (specifically, Medical Device) industry
• Possess expertise in Good Clinical Practice, including 21 CFR, ISO14155, ICH GCP
• Have robust auditing experience
• Hold a university degree, or equivalent in science or nursing

Responsibilities

• Manage project management, audit planning, executing the audit within the allotted time, issuing the audit report within the allotted time and the approval of the final audit report
• Provide clients with 80% auditor (hats on) and 20% mentor (hats off)
• Identify opportunities where RQM+ can provide additional support and assistance to the client. These opportunities shall be fed back the RQM+ business development team
• Support the training and development of junior auditors, providing them with guidance and support
• Identify and support the development of training modules required by the Audit Practice
• Maintain training in new / revised regulations, standards and guidances as they become available
• Arrange and host client meetings and conduct the audits
• Manage challenging situations and difficult conversations with clients with tact, diplomacy and integrity. Admit when wrong and maintain position when right

Preferred Qualifications

• Possess expertise in FDA BIMO Audit expectations
• Be familiar with ISO20916 and EU IVDR

Benefits

• Industry leading compensation package
• Focus on work life balance
• Ongoing learning and development opportunities