Job Summary

A technology company is searching for a person to fill their position for a Telecommuting Medical Consumables Regulatory Affairs Specialist.

Core Responsibilities Include:

• Communicating application progress to internal stakeholders
• Creating detailed written regulatory plans that can be used to target domestic and international shipment dates
• Providing timely and valued regulatory guidance

Qualifications for this position include:

• May require 5% travel annually with possibly some international
• Minimum 3 years of regulatory approvals and submittal experience
• Bachelor's degree or equivalent internationally-acquired qualifications
• Proficient knowledge of domestic and international standards
• Experience leading FDA 510(k) submissions and strategy
• Must be able to manage multiple tasks and perform with accuracy and a high attention to detail