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 requirements while working remotely to drive compliance efforts in a collaborative environment.

Key responsibilities

• Support Regulatory Actions related to 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.) (2+ years)
• Familiarity with FDA Documentation and EU Technical Documentation (2+ years)
• Experience in regulatory assessments for changes to medical devices (2+ years) is a plus
• Experience with CE marking requirements (2+ years) is a plus