Principal Compliance Audit Specialist

Job Summary

A company is looking for a Principal Compliance & Audit Specialist.

Key Responsibilities

• Plans, executes, and reports on internal audits in accordance with regulatory requirements and international standards
• Analyzes audit data and presents findings to management and regulatory bodies to support Corrective Action Plans
• Ensures compliance with internal and external regulatory agencies, investigating and resolving compliance violations

Required Qualifications

• Bachelor's degree or equivalent with a minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience
• Advanced knowledge of compliance and audit processes
• Understanding of global regulatory requirements for medical devices
• Technical experience in areas such as design controls, CAPA methodologies, and product security
• Experience in defining and implementing process improvement efforts