Regulatory Affairs Specialist

This position is responsible for the day-to-day regulatory activities for Henry Schein One’s dental imaging software. The Regulatory Affairs Specialist will assist with documentation, regulatory submissions, and quality system maintenance.

Requirements

• Bachelor’s degree in life sciences, engineering, regulatory affairs, or related field
• 1-3 years of regulatory affairs or related experience
• Familiarity with US FDA pathways for SaMD and 21 CFR Part 820
• Familiarity with regulatory frameworks in EU, UK, Canada, and Australia

Benefits

• Medical, Dental and Vision Coverage
• 401K Plan with Company Match
• Paid Time Off (PTO)
• Sick Leave
• Paid Parental Leave
• Short Term Disability
• Income Protection
• Work Life Assistance Program
• Health Savings and Flexible Spending Accounts
• Education Benefits
• Worldwide Scholarship Program
• Volunteer Opportunities