Senior Regulatory Affairs Associate

Job Summary

A company is looking for a Senior Regulatory Affairs Associate.

Key Responsibilities

• Collaborate with global regulatory bodies to support product market entry and maintenance
• Manage product distribution processes to ensure compliance and proper market release
• Identify and implement tools to enhance product distribution and communication processes

Required Qualifications, Training, and Education

• Bachelor's degree in a relevant field or equivalent experience required
• 2+ years of experience in a regulated industry required
• Experience with FDA and Software as a Medical Device preferred
• Strong knowledge of FDA Quality System Regulations and global regulatory filings
• Knowledge of Medical Devices Regulations and ISO standards preferred