Regulatory Affairs Consultant

Job Summary

A company is looking for a SAF Regulatory/Environmental Lead.

Key Responsibilities

• Conduct global regulatory change assessments and coordinate activities for assigned products
• Support global regulatory strategies for post-market changes and lead regulatory filings as needed
• Provide regulatory review of technical reports and documents while supporting risk management and vigilance reporting activities

Required Qualifications

• Bachelor's Degree in a scientific discipline (e.g., Chemistry, Chemical Engineering) or higher
• Minimum five (5) years of experience in regulatory affairs in the pharmaceutical and medical device industry
• Experience working on combination medical devices
• Direct experience authoring regulatory submissions and strategies
• Experience providing regulatory support for new product development teams