Senior Manager Regulatory Compliance

Job Summary

A company is looking for a Sr. Manager Regulatory Compliance, Supplier Quality.

Key Responsibilities

• Monitor and maintain compliance with applicable regulations (QSR, GMP, ISO) for product lifecycle and distribution
• Direct and manage complex supplier audits and internal audits to evaluate Quality Management Systems and regulatory compliance
• Lead investigations and resolutions related to the audit program while interfacing with various stakeholders

Required Qualifications

• Bachelor's degree in Engineering, Science, or a Technical Field
• At least 7 years of experience in medical device or drug combination product platforms, including compliance with QSR/GMP/ISO
• Minimum of 3 years of management experience
• Experience with risk management and design controls
• Direct experience with recall management is preferred