Job Summary

A healthcare company is in need of a Remote Principal Regulatory Affairs Specialist.

Individual must be able to fulfill the following responsibilities:

• Prepare and maintain US and non-US product submissions
• Review, approve, and provide guidance for labeling and advertising
• Maintain internal and external Regulatory Databases as necessary

Required Skills:

• Excellent verbal and written communication skills
• Excellent understanding a practical application of U.S. and international medical device regulations
• Knowledge and understanding of QSR and ISO quality management system documentation requirements
• Proficient with Microsoft 365 or similar software
• 7+ years experience in regulatory affairs in the medical device industry
• Bachelor's degree in engineering, computer science, the natural or biological sciences