Manager of Recall Processes

Job Summary

A company is looking for a Manager of Post Market Surveillance (Recall).

Key Responsibilities

• Lead the Recall process for medical products, including preparation of regulatory documentation and communications
• Manage Health Hazard Evaluations and collaborate with cross-functional teams to ensure timely completion
• Oversee Recall reporting activities and ensure compliance with global regulations and internal policies

Required Qualifications

• Bachelor's degree in Biomedical Science, Engineering, or a related field
• 4+ years of experience leading Health Hazard Evaluations and Recall strategies
• 5+ years of experience in Quality Management Systems
• Expert knowledge of FDA regulations and ISO standards related to medical devices
• Experience in Risk Management is preferred