Principal Regulatory Affairs Specialist (Remote - United States)

About the Role

This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations. The position offers the opportunity to strengthen responsible execution, improve decision-making, and support sustainable growth within a healthcare environment.

Responsibilities

• Serve as the regulatory affairs lead for product-line submissions and registrations for the Dental Solutions business
• Drive regulatory strategy for major markets while collaborating with international teams for global registration
• Conduct regulatory change assessments and coordinate related activities for drug and medical device products
• Lead or support regulatory filings for continuity projects in the U.S. and EU, as well as collaborate with global teams for other markets
• Provide regulatory reviews and input on technical documentation related to the company spin-off

Qualifications

• Bachelor's Degree or higher in a related field and seven years of regulatory affairs experience in the drug and/or medical device industry
• Experience authoring regulatory submissions and technical documentation for drug and medical device products in the U.S., Canada, and Europe with knowledge of EMEA, APAC, and LATAM regulations
• Experience in developing regulatory strategies and conducting regulatory change assessments
• Proficient in reviewing and approving product labeling for compliance with global regulatory requirements
• Familiarity with NDA and OTC monograph drugs and medical devices

Benefits

• Programs to support physical and financial well-being
• Healthcare benefits including Medical, Dental & Vision coverage
• Health Savings Accounts and Flexible Spending Accounts
• Disability Benefits and Life Insurance options
• Paid absences and Retirement Benefits

Location: Remote - US based candidates only, no visa sponsorship available
Compensation: $142,800 – $196,350 annually