Senior Regulatory Specialist

Job Summary

A company is looking for a Senior Regulatory Specialist.

Key Responsibilities:

• Conduct regulatory research and provide guidance for new product development
• Author pre-submissions and 510(k)s for US FDA
• Manage global regulatory approvals and collaborate with external partners

Required Qualifications:

• 5-7 years of experience in Regulatory Affairs
• Minimum 3 years of software medical device experience
• In-depth knowledge of global regulatory requirements
• Demonstrated collaboration with marketing and clinical for strategic regulatory claims
• Demonstrated leadership skills