Principal Regulatory Affairs Specialist - Remote

Overview

The Principal Regulatory Affairs Specialist will lead regulatory submissions and registrations for the Dental Solutions business across global markets, ensuring compliance and supporting product development.

In Short

• Lead regulatory affairs on cross-functional teams.
• Drive regulatory strategy for high-volume markets.
• Conduct global regulatory change assessments.
• Support regulatory filings for drug and medical devices.
• Communicate regulatory outcomes to stakeholders.
• Implement digital and AI-enabled solutions in regulatory processes.
• Ensure compliance with global regulatory requirements.
• Participate in continuous improvement of regulatory processes.
• Support risk management and quality initiatives.
• Work remotely from the United States.

Requirements

• Bachelor’s Degree or higher in relevant field.
• 10 years of regulatory affairs experience.
• Experience with regulatory submissions in the US, Canada, and EU.
• Knowledge of dental products and regulatory compliance.
• Experience authoring regulatory strategies and assessments.
• Strong communication skills for cross-functional collaboration.
• Ability to manage multiple product portfolios.
• Experience with clinical strategy for medical devices.
• Familiarity with process improvement approaches.
• Legally authorized to work in the USA.

Benefits

• Competitive pay and benefits.
• Medical, Dental & Vision insurance.
• Health Savings Accounts.
• Retirement benefits.
• Flexible Spending Accounts.
• Disability and Life Insurance.
• Paid absences.
• Support for professional development.
• Well-being programs.
• Work-life balance support.