Sr. Regulatory Affairs Specialist

Join our mission-driven Regulatory Affairs team as the Sr. Regulatory Affairs Specialist at Endologix! We're committed to improving patients' lives through innovative therapies for the interventional treatment of vascular disease. Our team fosters a forward-thinking, mission-driven environment where every team member plays a vital role in advancing patient care.

Requirements

• Bachelor's degree in scientific discipline or equivalent education and experience
• Minimum 5+ years of medical device experience with 1+ years of experience in Regulatory Affairs
• In-depth knowledge of FDA, EU MDR, and global medical device regulations
• Strong understanding of design controls, ISO 13485, and risk management principles
• Proven ability to manage multiple regulatory submissions, track competing deadlines, and collaborate effectively with cross-functional teams

Benefits

• Comprehensive health, dental, and vision insurance plans
• Flexible Health Savings Accounts (HSAs) and/or Flexible Spending Accounts (FSAs)
• 401(k) retirement plan with company match
• Generous paid time off (vacation, sick leave, holidays, and flexible time off that is available for Exempt employees)
• Flexible work arrangements, such as hybrid or remote work for many of our positions
• Employee wellness initiatives, mental health resources, and Employee Assistance Program (EAP)
• Employee recognition programs and awards
• Learning and development opportunities
• Commuter benefits or transportation stipends
• Company events and team-building activities