Job Summary

• Regulatory Affairs Specialist performs specialized work assignments relative to the analysis, evaluation, preparation and submission of documentation to regulatory agency specifications for global market entry.
• You will also be responsible for development, review, and maintenance of internal documentation.
• Participate in project teams to develop regulatory strategies, testing requirements, and other documentation to ensure that new product regulatory submissions meet the company’s product launch timelines in all identified markets.

Matching Summary

Skills & Requirements

Key Requirements

• Bachelor’s degree and 2-year minimum work experience
• 4 years minimum work experience in regulatory affairs
• Knowledge of national and international quality and regulatory laws
• Ability to write detailed technical regulatory submissions
• Ability to write detailed clinical evaluation reports
• Experience submitting premarket submissions to the FDA (510(k))
• Submitted EU Technical Documentation to a Notified Body

Work Rights