Lead Auditor Regulatory Affairs

Job Summary

A company is looking for a RA Spec III.

Key Responsibilities

• Coordinate internal, external, and customer audits to foster a quality environment
• Ensure alignment of local and regional procedures with global quality standards
• Manage documentation related to quality certificates and audit reports

Required Qualifications

• Bachelor's degree or equivalent in Biology, Chemistry, Medical Technology, or related field
• Qualified Lead Auditor with relevant training; certification preferred
• 5 years of experience in a regulated industry or equivalent education and experience
• Working knowledge of global regulations such as 21 CFR and ISO standards
• Experience with Artificial Intelligence is preferred