Regulatory Affairs Specialist

Join Endologix as a Regulatory Affairs Specialist to support, develop, and drive the timely preparation of regulatory submissions and product updates necessary to obtain and maintain regulatory approvals for Endologix products.

Requirements

• Bachelor's degree in scientific discipline or equivalent education and experience
• Typically has minimum 2-5 years of medical device experience with 1+ years of experience in Regulatory Affairs
• Experience with US Class III cardiovascular devices strongly preferred
• In-depth knowledge of FDA, EU MDR, and global medical device regulations
• Solid understanding of design controls, ISO 13485, and risk management principles
• Exceptional attention to detail with the ability to analyze complex data and produce clear, accurate, and compliant documentation
• Proven ability to manage multiple submissions, prioritize deadlines, and collaborate effectively across cross-functional teams
• Effective communicator with high ethical standards, ensuring labeling, advertising, and promotional materials meet regulatory requirements

Benefits

• Base salary of $90,000/yr-$102,500/yr
• Discretionary bonus
• Equity participation
• Comprehensive health, dental, and vision insurance plans
• Flexible Health Savings Accounts (HSAs) and/or Flexible Spending Accounts (FSAs)
• Generous paid time off
• 401(k) retirement plan with company match