Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist will serve as a regulatory lead expert supporting the expansion of our Software as a Medical Device (SaMD) portfolio across global markets. The role is critical as we scale our medical device offerings and strengthen our global regulatory posture.

Requirements

• Regulatory expertise in SaMD regulations and software standards
• Strong communication and project leadership skills
• 5–7+ years of regulatory affairs experience in SaMD or medical device
• Demonstrated success leading FDA 510(k), De Novo, and EU MDR submissions
• Bachelor's degree in Life Sciences, Engineering, or Regulatory Science; advanced degree preferred

Benefits

• Medical, Dental, & Vision Plans
• 401(k)
• FSA/HSA
• Commuter Benefits
• Tuition Assistance Plan
• Vacation and Sick Time
• Paid Parental Leave