Staff Regulatory Affairs Specialist

Job Summary

Providing regulatory leadership throughout the product lifecycle, the full-time Staff Regulatory Affairs Specialist will develop and execute global regulatory strategies, participate in product development teams, and manage regulatory submissions for medical devices in a remote capacity.

Key responsibilities

• Develop and execute global regulatory strategies for new products and lifecycle management activities
• Participate in product development teams to ensure compliance with regulatory requirements across various markets
• Author and submit regulatory filings, including FDA submissions and international registrations

Required qualifications

• Bachelor's degree in Engineering, Sciences, Regulatory Affairs, or a related field
• Minimum 4 years of experience in an FDA-regulated industry
• Minimum 3 years of Regulatory Affairs experience
• Experience preparing regulatory submissions for product approvals