Principal Regulatory Affairs Specialist (Remote - United States)

Responsibilities

• Lead the preparation and submission of 510(k) applications and other regulatory filings for SaMD
• Develop and execute global regulatory strategies for product registrations in the US, EU, and Canada
• Support international regulatory teams in product registrations across the Custom Smiles Portfolio
• Ensure compliance with global regulations and review technical documentation for submissions
• Integrate regulatory requirements into product development across teams

Qualifications

• Bachelor’s Degree or higher with 7+ years of regulatory affairs experience in medical devices, or a High School Diploma/GED with 11+ years of experience
• Five years of experience specifically with Software as a Medical Device (SaMD)
• Proven experience in submitting regulatory documentation in the US and EU
• Experience communicating complex regulatory requirements and collaborating with cross-functional teams

Pay

$142,800 – $196,350 annually

Schedule

Remote - US based candidates only, no visa sponsorship available

Benefits

• Comprehensive health benefits including Medical, Dental, and Vision coverage
• Health Savings Accounts and Flexible Spending Accounts for healthcare expenses
• Disability benefits and Life Insurance options
• Paid Absences and Retirement Benefits offerings
• Programs designed to support physical and financial well-being

Our Client

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.