Senior Regulatory Affairs Specialist

Job Summary

A company is looking for a Senior Regulatory Affairs Specialist.

Key Responsibilities:

• Develop regulatory strategies and oversee activities for obtaining and maintaining regulatory approvals
• Prepare and submit US and International regulatory submissions
• Ensure compliance with FDA, EU, ISO, and other regulatory requirements and standards

Required Qualifications:

• Bachelor's degree in a related field
• 7+ years of experience in US and International medical device regulatory submission/approval
• Knowledge of FDA Quality System regulations and ISO requirements
• Experience with FDA, MDD, PMDA, TGA, and TPD
• Strong communication and technical writing skills