Senior Regulatory Affairs Specialist

Job Summary

Supporting a high-visibility regulatory change initiative, the contract Senior Regulatory Affairs Specialist will leverage expertise in medical device regulations and documentation while working remotely to ensure compliance and drive project efficiency.

Key responsibilities

• Support Regulatory Actions associated with a Legal Manufacturer address change
• Participate in Project Shift meetings and provide progress updates
• Execute project-related tasks efficiently and accurately

Required qualifications

• Bachelor's Degree in a related field or 4+ years in the medical device industry
• Familiarity with medical device labeling (IFUs, Product Labels, etc.) for 2+ years
• Familiarity with FDA Documentation and EU Technical Documentation for 2+ years
• Experience in regulatory assessments for changes to medical devices is a plus
• Experience with CE marking requirements and regulatory review of advertising materials is a plus