Senior Regulatory Affairs Specialist

Job Summary

To support regulatory activities for a Legal Manufacturer address change project, the full-time Senior Regulatory Affairs Specialist will manage FDA submissions, review medical device labeling, and ensure compliance with regulatory requirements while working remotely for a temporary duration of 7 months.

Key responsibilities

• Support regulatory activities associated with a Legal Manufacturer address change project
• Review and update medical device labeling and associated documentation as required
• Collaborate with cross-functional teams to ensure compliance with applicable regulatory requirements

Required qualifications

• Bachelor's degree in a related field (Life Sciences, Regulatory Affairs, Engineering, or a related discipline)
• Minimum 5 years of experience in Regulatory Affairs or Medical Device Labeling
• Experience with FDA regulatory documentation and EU technical documentation
• Strong knowledge of medical device regulatory requirements and change management processes
• Experience reviewing advertising and promotional materials for regulatory compliance